22
Parks Medical Electronics, Inc.
Aloha, Oregon U.S.A.
Technical Information and Notes
Electrical Safety
CAUTION!
This instrument is intended for use by health care professionals only.
Follow the operating manual instructions for the use of this equipment.
Misuse of this equipment and inappropriate electrical connections can create a shock hazard.
What may appear to be a simple connection to other equipment can put the patient and/or the
operator at risk of electrical shock.
The following is a guide to avoiding common potential hazards. It is not comprehensive. Always seek
the advice of a quali
fi
ed bioengineer before making any electrical connections.
1. Use caution when connecting the Doppler to other equipment.
Connecting the Doppler to a computer, ampli
fi
er or intercom system can be extremely hazardous.
There is a shock hazard unless a medical grade isolation transformer is used. The combined
equipment must comply with medical systems standard 60601-1-1 for the safety of the patient
and the operator. Have a quali
fi
ed technician or bioengineer review and approve any proposed
connections.
2. Operate this instrument only with the prescribed battery as the power source.
This device cannot be used while connected to a charger.
3.
The battery charging circuits in this Doppler have been designed to prevent operation while the
battery charger is connected to provide protection from electric shock.
4. Do not rewire or modify the battery charging circuitry in this Doppler.
The battery charger must comply with the relevant national requirements:
EN60601-1:1990 +A1:1993+A2:1995.
The battery charging input circuitry must not be modi
fi
ed or altered in the
fi
eld.
Changing this safety feature would compromise safety and violate 21 CFR 898.12.
5. Do not use this instrument in the presence of fl ammable gas or high oxygen
concentrations.
6. Do not position this instrument so that it comes in contact with metal
surfaces, cautery, or other electronic equipment during use.
Burns can occur through the probe if the Doppler’s metal case is inadvertently grounded when
the electrocautery back plate is not connected properly. To protect against this, ensure that the
cautery instrument’s ground plate is on, and only suspend the Doppler from an insulator if it is
hung on an IV pole.
7.
Inspect the probe covering for damage before each use.
Before using the probe, inspect for any cracks or breaks in the protective epoxy covering.
Damage that could allow for ingress of conductive
fl
uids, such as acoustical coupling gel, can
create a shock or burn hazard if the Doppler’s metal case is grounded and comes in contact with
or is used with other electronic equipment.
8. This instrument should not be used with a defi brillator.
Parks assumes no responsibility for the misuse of this equipment.
Summary of Contents for 915-BL
Page 2: ...2 Parks Medical Electronics Inc Aloha Oregon U S A ...
Page 24: ...24 Parks Medical Electronics Inc Aloha Oregon U S A ...
Page 26: ...26 Parks Medical Electronics Inc Aloha Oregon U S A Appendix ...
Page 27: ...27 915 BL Dual Frequency Doppler Appendix ...
Page 28: ...28 Parks Medical Electronics Inc Aloha Oregon U S A Appendix ...