USER SAFETY INFORMATION
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situated outside the patient environment per IEC 60601-1–1. To ensure the safety of the patient it must not be
possible for the operator to touch the patient and the computer at the same time. In general, at least 1.5 meters
(5’) of open area must surround the patient to achieve this.
11.
If the personal computer is situated within the patient environment, ensure that its level of safety is that of
medical electrical equipment per IEC 60601-1. This may be accomplished by powering the computer and any
other equipment connected to it through an isolation transformer or by operating on battery power.
12.
If the personal computer is situated within the patient environment, to maintain designed operator and patient
safety when a LAN network connection is being used, the network cable must be connected to the device
through an Ethernet isolator module that complies with IEC 60601-1-1 (available from Welch Allyn).
13.
ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation.
Electrode materials and ingredients are specified on the packaging or are available from the vendor upon
request.
14.
To avoid the possibility of serious injury or death during patient defibrillation, do not come into 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.
15.
Proper clinical procedure must be employed to prep the electrode sites and to monitor the patient for excessive
skin irritation, inflammation, or other adverse reactions. Electrodes are intended for short-term use and should
be removed from the patient promptly following testing. Do not mix electrodes made of dissimilar metals.
16.
To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes) must
not be reused. To maintain safety and effectiveness, electrodes must not be used beyond their expiration date.
17.
A possible explosion hazard exists. Do not use the device in the presence of flammable anesthetic mixture.
18.
Possible malfunction risks may be present when installing third-party software. Welch Allyn, Inc. cannot verify
the compatibility of all possible hardware/software combinations.
19.
The device has not been designed for use with high-frequency (HF) surgical equipment and does not provide a
protective means against hazards to the patient.
20.
When the 40 Hz filter is used, the frequency response requirement for diagnostic ECG equipment cannot be
met. The 40 Hz filter significantly reduces high-frequency components of the ECG and pacemaker spike
amplitudes, and is recommended only if high-frequency noise cannot be reduced by proper procedures.
21.
The quality of the signal produced by the device may be adversely affected by the use of other medical
equipment, including but not limited to defibrillation and ultrasound machines.
22.
Use only recommended alkaline battery cells with WAM™. Use of other cells may present a risk of fire or
explosion.
23.
The WAM low battery warning function is designed for alkaline battery cells only. Use of other cells may
result in failure of the low battery warning possibly resulting in a malfunction of the device.
24.
Test RScribe functions after each Microsoft critical and security update with a simulator prior to patient use.
25.
Damaged or suspected inoperative equipment must be immediately removed from use and must be
checked/repaired by qualified service personnel prior to continued use.
