CP 150 12-lead resting electrocardiograph Service manual

Safety

All users of the device must read and understand all safety information presented in this manual before using or repairing the device.

United States federal law restricts this device to sale, distribution, or use by or on the order of a licensed medical practitioner.

General warnings

Warnings indicate conditions or practices that could lead to illness, injury, or death.

Warnings related to the environment

WARNING The power cord is considered the disconnect device for isolating this equipment from supply mains. Do not position the equipment so that it is difficult to reach or disconnect.

WARNING To avoid a possible explosion, do not use the electrocardiograph in the presence of flammable anesthetics: mixtures containing air, oxygen, or nitrous oxide.

WARNING When transporting the electrocardiograph on a cart, tuck the patient cable away to keep them clear of the wheels and to minimize trip hazards.

Warnings related to accessories and other equipment

WARNING To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

WARNING For operator and patient safety, peripheral equipment and accessories that can come in direct patient contact must be in compliance with all appropriate safety, EMC, and regulatory requirements.

WARNING All signal input and output (I/O) connectors are intended for connection of only devices complying with IEC 60601-1, or other IEC standards (for example, IEC 60950), as appropriate to the device.

Connecting additional devices to the electrocardiograph might increase chassis or patient leakage currents.

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6 Safety CP 150 12-lead resting electrocardiograph

WARNING The electrocardiograph has not been designed for use with high-frequency (HF) surgical equipment and does not protect against hazards to the patient.

WARNING Defective batteries can damage the electrocardiograph.

Visually inspect the battery at least monthly, if the battery shows any signs of damage or cracking, it must be replaced immediately and only with a battery approved by Welch Allyn.

WARNING Improper disposal of batteries may create an explosion or contamination hazard. Never dispose of batteries in refuse containers.

Always recycle batteries according to local regulations.

WARNING All signal input and output (SIP/SOP) connectors should not be contacted by patient directly and indirectly through the user during operation.

Warnings related to using the electrocardiograph

WARNING No modification of this equipment is allowed.

WARNING This device captures and presents data reflecting a patient’s physiological condition. When reviewed by a trained physician or clinician, this data can be useful in determining a diagnosis. However, the data should not be used as a sole means for determining a patient’s diagnosis or prescribing treatment.

WARNING To provide CF protection use only accessories approved by

Welch Allyn. Visit www.welchallyn.com. The use of any other accessories can result in inaccurate patient data, can damage the equipment, and can void your product warranty.

WARNING To avoid serious injury or death, take these precautions during patient defibrillation:

• Avoid contact with the electrocardiograph, patient cable, and patient.

• Verify that the patient leads are properly connected.

• Place defibrillator paddles properly in relation to electrodes.

• After defibrillation, pull each patient lead out of the patient cable and inspect the tips for charring (black carbon marks). If there is any charring, the patient cable and individual leads must be replaced. If there is no charring, fully reinsert the leads into the patient cable. (Charring can occur only if a lead is not fully inserted into the patient cable before defibrillation.)

WARNING To prevent the spread of infection, take these precautions:

• Dispose of single-use components (for example, electrodes) after using them once.

• Regularly clean all components that come in contact with patients.

• Avoid ECG testing for patients with open, infectious sores.

WARNING Avoid positioning any leads or cables so that they could easily trip someone or become wrapped around a patient’s neck.

Service manual Safety 7

WARNING To ensure safe use of the device, follow the documented maintenance procedures.

WARNING Only qualified service personnel should attempt to repair the electrocardiograph. In case of a malfunction, call Technical Support.

WARNING Do not perform ST segment analysis on the ECG screen display, since these ECG representations are scaled. Make manual measurements of ECG intervals and magnitudes on printed ECG reports only.

General cautions

WARNING To maintain diagnostic accuracy and to comply with IEC

60601-02-51 and IEC 60601-02-25, do not scale (re size) when sending a saved ECG to an external printer.

WARNING To avoid injury, do not touch the print head immediately after printing. It might be hot.

Cautions indicate conditions or practices that could damage the equipment or other property.

CAUTION When removing the electrocardiograph from storage, allow it to thermally stabilize to surrounding environmental conditions before using it.

CAUTION To prevent possible damage, do not use sharp or hard objects to press the touch screen or the buttons. Only use fingertips.

CAUTION Do not expose the patient cable to strong ultraviolet radiation.

CAUTION Do not pull or stretch the patient cable. Doing so could result in mechanical or electrical failures. Form the patient cable into a loose loop before storing.

CAUTION Avoid positioning the patient cable where it might get pinched, stretched, or stepped on. Otherwise, measurements might no longer be accurate, and repair might be necessary.

CAUTION Using the equipotential terminal for anything but grounding purposes may contribute to damage of the device.

CAUTION Use only parts and accessories, including thermal paper, that were supplied with the device and available through Welch Allyn. The use of accessories other than those specified may result in degraded performance or unsafe use of this device.

CAUTION Portable and mobile RF communications equipment can affect the performance of the electrocardiograph.

CAUTION The electrocardiograph meets the Class A requirements of IEC

60601-1-2 regarding incidental emission of radio frequency interference. As such it is suitable for use in commercial grade electrical environments. If the electrocardiograph is used in residential grade electrical environments and you experience incidental interference with other equipment that uses radio frequency signals to operate, minimize the interference.

8 Safety CP 150 12-lead resting electrocardiograph

Note

CAUTION Other medical equipment—including but not limited to defibrillators, ultrasound machines, pacemakers, and other stimulators— may be used simultaneously with the electrocardiograph. However, such devices may disturb the electrocardiograph signal.

CAUTION The power cord must be disconnected from AC power before cleaning, maintaining, transporting, or servicing.

CAUTION The requirements of AAMI EC11, Section 3.2.7.2, Frequency and Impulse Response, for an impulse triangle waveform may be impacted by up to 5 milliseconds of small amplitude dampened ringing immediately after the impulse when the muscle filter (35 Hz) is turned on or a small amplitude offset when the baseline filter (0.5 Hz) is turned on. These filters, in any combination turned on or off, meet the AAMI requirements.

Measurements performed by the optional interpretation algorithm are unaffected by any filter selections.

The entire patient cable, up to and including the electrodes are considered to be an Applied Part.

General safety considerations

• To ensure patient safety, use only accessories recommended or supplied by Welch

Allyn. Always use accessories according to your facility’s standards and according to the manufacturer’s recommendations and instructions. Always follow the manufacturer’s directions for use.

• Welch Allyn recommends that only Welch Allyn service personnel or an authorized repair center perform warranty service. Performing unauthorized service on a device that is within warranty may void the warranty.

Service manual

Electrostatic discharge (ESD)

Safety 9

CAUTION Electrostatic discharge (ESD) can damage or destroy electronic components. Handle static-sensitive components only at static-safe workstation.

CAUTION Assume that all electrical and electronic components of the device are static-sensitive.

Electrostatic discharge is a sudden current flowing from a charged object to another object or to ground. Electrostatic charges can accumulate on common items such as foam drinking cups, cellophane tape, synthetic clothing, untreated foam packaging material, and untreated plastic bags and work folders, to name only a few.

Electronic components and assemblies, if not properly protected against ESD, can be permanently damaged or destroyed when near or in contact with electrostatically charged objects. When you handle components or assemblies that are not in protective bags and you are not sure whether they are static-sensitive, assume that they are staticsensitive and handle them accordingly.

• Perform all service procedures in a static-protected environment. Always use techniques and equipment designed to protect personnel and equipment from electrostatic discharge.

• Remove static-sensitive components and assemblies from their static-shielding bags only at static-safe workstations—a properly grounded table and grounded floor mat— and only when you are wearing a grounded wrist strap (with a resistor of at least 1 megohm in series) or other grounding device.

• Use only grounded tools when inserting, adjusting, or removing static-sensitive components and assemblies.

• Remove or insert static-sensitive components and assemblies only with device power turned off.

• Insert and seal static-sensitive components and assemblies into their original staticshielding bags before removing them from static-protected areas.

• Always test your ground strap, bench mat, conductive work surface, and ground cord before removing components and assemblies from their protective bags and before beginning any disassembly or assembly procedures.

10 Safety CP 150 12-lead resting electrocardiograph