Welch Allyn Hillrom H12+, User Manual

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7
USER SAFETY INFORMATION
WARNING: Means there is the possibility of personal injury to you or others.
Caution: Means there is the possibility of damage to the device.
Note:
Provides information to further assist in the use of the device.
WARNING(S)
This manual gives important information about the use and safety of this device. Deviating from
operating procedures, misuse or misapplication of the device, or ignoring specifications and
recommendations could result in increased risk of harm to users, patients and bystanders, or damage to
the device.
Any serious incident that has occurred in relation to the H12+ should be reported to Welch Allyn and the
competent authority of the Member State in which the user or patient is established.
Caretakers must closely supervise an infant or child who is wearing a Holter recorder to ensure the
recorder is intact and the patient cable is properly secured.
Device
stores data reflecting a patient’s physiological condition to a properly equipped analysis system
that when reviewed by a trained physician or clinician can be useful in determining a diagnosis; however,
the data should not be used as a sole means for determining a patient’s diagnosis.

Users are expected to be licensed clinical professionals knowledgeable about medical procedures
and patient care, and adequately trained in the use of this device. Before attempting to use this
device for clinical applications, the operator must read and understand the contents of the user
manual and other accompanying documents. Inadequate knowledge or training could result in
increased risk of harm to users, patients and bystanders, or damage to the device. Contact Welch
Allyn service for additional training options.

To maintain designed operator and patient safety, peripheral equipment and accessories that can
come in direct patient contact must be in compliance with UL 60601-1, IEC 60601-1, and IEC 60601-
2-47. Only use parts and accessories supplied with the device and available through Welch Allyn.

Patient cables intended for use with the device include series resistance (9 Kohm minimum) in each
lead for defibrillation protection. Patient cables should be checked for cracks or breakage prior to
use.

Conductive parts of the patient cable, electrodes, and associated connections of type CF applied
parts, including the neutral conductor of the patient cable and electrodes, should not come into
contact with other conductive parts including earth ground.

ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or
inflammation.

To avoid the possibility of serious injury or death during patient defibrillation, do not come in contact
with device or patient cables. Additionally, proper placement of defibrillator paddles in relation to the
electrodes is required to minimize harm to the patient.

Defibrillation protection is guaranteed only if the original patient cable is used. Any modification of
this device may alter defibrillator protection.