User's Manual Part 1
1-1
1. Preface
1.1. About 3880 Non-Magnetic Patient Monitoring Systems
1.1.1. Intended Use
The IRadimed Corporation’s 3880 MRI Patient Monitoring System is intended to monitor a
single patient’s vital signs for patients undergoing Magnetic Resonance Imaging (MRI)
procedures.
The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals.
The 3880 MRI Patient Monitoring System is intended for use in Adult, Pediatric, and Neonatal
populations for monitoring of Electrocardiogram (ECG), Non-Invasive Blood Pressure (NIBP),
Temperature, Pulse Oximetry (SpO
2
), Respiration, Capnography (CO
2
), Oxygen, and
Anesthetic Agents.
Patient types as identified herein regard pediatric patient types as not including neonates. The
definitions of pediatric patient types and associated ages is as below and per FDA guidance:
• Neonates: from birth through the first 28 days of life
• Infants: 29 days to less than 2 years
• Children: 2 years to less than 12 years
• Adolescents: aged 12 through 21 (up to but not including the 22nd birthday)
The 3886 Multi-Gas unit is intended for use in adult and pediatric populations, not including
neonates.
1.1.2. Intended Audience
This manual is intended for clinical professionals who are expected to have a working
knowledge of medical procedures, practices and terminology as required for radiology and the
monitoring of high acuity patients.
The 3880 MRI Patient monitoring system, the pulse oximeter oPOD and ECG ePOD are to be
operated by, or under the supervision of, qualified personnel only. The manual, accessories,
directions for use, all precautionary information, and specifications should be read before use.
1.1.3. Equipment Classification and System Items
The 3880 MRI Patient Monitor System includes the following items:
3880 Monitor Unit
3881 ePOD ECG telemeter unit
3882 oPOD SpO2 telemeter unit
1120 Charger with cords and cable
1200 Operation Manual
Optional equipment includes:
3885-T Remote Control Tablet, Wireless (must be used with 3885-B)
3885-B Base Unit, Mains powered, Wireless Connect (must be used with 3885-T)
3886 Multi-Agent Gas Unit