EDAN Acclarix AX15, Руководство пользователя

Страница: 9 / 149

Acclarix AX3 Series Diagnostic Ultrasound System User Manual Safety
- 3 -

Contact with natural rubber latex may lead to a severe anaphylactic reaction in persons
sensitive to the natural latex protein, Sensitive users and patients must avoid contact with
these items. EDAN strongly recommends that health-care professionals identify their
latex-sensitive patients, and refer to the March 29, 1991 Medical Alert on Latex products. Be
prepared to treat allergic reactions immediately.

Improper operation may cause the internal lithium battery (hereinafter called battery) to
become hot, ignited or possibly explode, and it may lead to decreased battery capacity. It is
necessary to read the user manual instructions and warning messages carefully.

Do not touch accessible contacts of electrical equipment and the patient simultaneously.

This device is not suitable for intra-cardiac use or direct cardiac contact.

The system shall not be serviced or maintained while in use during an exam.

Install the system according the EMC guidance provided in Appendix D.

Do not stack the system on other electronic equipment.

The use of transducer and connecting cable not supplied by the manufacturer may result in
increased emissions or decreased immunity of the equipment.

Refer to Appendix D for recommended separation distances from other equipment, including
portable and RF communication devices.

The power adapter is used to isolate the system from main power. Position the system so that
it is easy to disconnect it from the power supply.

No modification of this equipment is allowed.

The system should be maintained regularly, at least annually, by a qualified technician who
has adequate training, knowledge and experience. That person should be familiar with the
Service Manual, available from your Edan representative.

Keep non-medical equipment out of the vicinity of the patient. (1.5m/6ft.)

Use of an extension cord or multi-socket outlet setup to provide power to the ultrasound
system or to the system‟s peripheral devices, may compromise the system grounding and
cause the system to exceed current leakage limits.

It is not suggested to use a multiple socket-outlet with the device. If one is required, make sure
that the multi-socket complies with the requirement specified in Chapter 16 of IEC 60601-1, or
the multi-socket is with an isolation transformer. And the multi-socket shall not be placed on
the floor.

SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied as a part
of the system, to the multiple portable socket-outlet supplying the system.

SHOCK HAZARD - Don't connect non-electrical equipment, which has been supplied as a part
of the system, directly to the wall outlet when the non-medical equipment is intended to be
supplied by a multiple portable socket-outlet with an isolation transformer.

SHOCK HAZARD
– Do not connect non-isolated electrical equipment to the same circuit
being used to power the system.

Edan recommends the use of isolated connectors on any electrical equipment attached to the
system, and/or using isolation transformers that comply with IEC60601-1 to power that
electrical equipment.

Always use sterile technique during a biopsy procedure. Sterilize the needle guide assembly
between uses.

Use a sterile needle with each use.

The system may be interfered with by other equipment, even if that other equipment complies
with CISPR EMISSION requirements.

The system cannot be used together with high-frequency surgical equipment.