Safety Manual
Table Of Contents
- Table of Contents
- Publication Information
- Regulatory Information
- Intended Use
- Indications for Use
- Contraindications
- Prescription Device Statement
- Classification of Medical Device
- Recording ECGs during Defibrillation
- Modulating Effects in Digital Systems
- Biocompatibility
- Legal Notice
- Responsibility of the Manufacturer
- Responsibility of the Purchaser/Customer
- Warranty Information
- Safety Information
- Product and Packaging Information
- Equipment Identification
- Electromagnetic Compatibility (EMC)
- Wireless Regulations
Safety Information
equipment contains no user-serviceable parts. Refer servicing to authorized
service personnel.
CAUTION:
EQUIPMENT COMPATIBILITY
Compatibility is critical to safe and effective use of this device. Please contact
your local sales or service representative prior to installation to verify equipment
compatibility.
WARNING:
PERSONAL INJURY-STUMBLING HAZARD - Patients can become entangled in the
cables and leadwires connected to the device, which could cause the patient to
stumble or trip.
Route cables and leadwires in a way to avoid creating a stumbling hazard: keep
them off the floor, and route leadwires away from the patient’s legs and the
healthcare provider’s work area.
WARNING:
MAGNETIC AND ELECTRICAL INTERFERENCE - Magnetic and electric fields can
interfere with the acquisition of ECG readings.
Make sure that all peripheral components operated in the vicinity of the device
comply with the relevant EMC requirements. X-ray equipment, MRI devices,
radio systems (cellular phones) and so forth, are possible sources of interference
because they may emit higher levels of electromagnetic radiation. Verify the
performance of the system before use.
WARNING:
EXPLOSION HAZARD - Using this device in the presence of anesthetic vapors or
liquids can cause explosions.
Do not use this device in the presence of anesthetic vapors or liquids. Only persons
with adequate training in the correct use of this device may use this device.
WARNING:
EQUIPMENT FAILURE - Polarizing electrodes (stainless steel or silver constructed)
may cause the electrodes to retain a residual charge after defibrillation. A residual
charge blocks acquisition of the ECG signal.
Whenever patient defibrillation is a possibility, use non-polarizing electrodes
(silver-silver chloride construction) for ECG monitoring.
CAUTION:
EQUIPMENT DAMAGE
Devices intended for emergency application must not be exposed to low
temperatures during storage and transport to avoid moisture condensation at the
application site. Wait until all moisture has vaporized before using the device.
2109599-003 A MAC
™
7 Resting ECG Analysis System 9