Product Manual

USER SAFETY INFORMATION
12
• This product complies with relevant electro-magnetic interference, mechanical safety, performance,
and biocompatibility standards. However, the product cannot completely eliminate potential patient or
user harm from the following:
• Harm or device damage associated with electro-magnetic hazards,
• Harm from mechanical hazards,
• Harm from device, function, or parameter unavailability,
• Harm from misuse error, such as inadequate cleaning, and/or
• The device and IT Network the device is connected to should be securely configured and maintained
per the IEC 80001 standard, or an equivalent network security standard or practice.
Caution(s)
• To prevent possible damage to the keyboard, do not use sharp or hard objects to depress keys,
only use fingertips.
• Do not attempt to clean the device or patient cables by submersing into a liquid, autoclaving, or steam
cleaning as this may damage equipment or reduce its usable life. Wipe the exterior surfaces with a warm
water and mild detergent solution and then dry with a clean cloth. Use of unspecified cleaning/disinfecting
agents, failure to follow recommended procedures, or contact with unspecified materials could result in
increased risk of harm to users, patients and bystanders, or damage to the device.
• No user-serviceable parts inside. Screw removal by qualified service personnel only. Damaged or
suspected inoperative equipment must be immediately removed from use and must be
checked/repaired by qualified service personnel prior to continued use.
• The rechargeable internal battery is a sealed lead-acid type and it is totally maintenance free. If the
battery appears to become defective, refer to Welch Allyn Service Department.
• Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. Patient
cables should be stored after forming them into a loose loop.
• No calibration or special equipment is needed for the proper operation or maintenance of the device.
● When necessary, dispose of the device, its components and accessories (e.g., batteries, cables,
electrodes), and/or packing materials in accordance with local regulations.
• Use only No. 26 AWG or larger telecommunication line cord.
Note(s)
• Patient movements may generate excessive noise that may affect the quality of the ECG traces and the
proper analysis performed by the device.
• Proper patient preparation is important to proper application of ECG electrodes and operation of the device.
• The algorithm detecting electrode misplacements is based on normal physiology and ECG lead order, and
tries to identify the most likely switch; however, it is advisable to check the other electrode positions in the
same group (limb or chest).
• There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is
used simultaneously with the device; however, disturbance to the signal may occur.