User's Manual Part 1

1-2
Classification according to IEC 60601-1
Type of protection against electrical
shock
Class I ME Equipment 3880, 3886
Note: 3881 and 3882 are Internally
powered Body Worn
Degree of protection against electrical
shock
Type CF (defibrillator-proof) equipment
for use in Patient Environment - 3880,
3886, 3881 ePOD, 3882 oPOD
Degree of protection against harmful
ingress of water and particulate matter
IPX1 enclosed equipment protected
against harmful effects of dripping water
per IEC 60529
Note: Optional 3885-B Base Station,
3885-T Remote Tablet and 3886 Multi-
Gas Unit are Ordinary Equipment
(enclosed equipment without protection
against ingress of water) used outside of
Patient Environment
Methods of Sterilization or disinfection
Non-Sterilizable, Use of liquid surface
disinfectants only
Mode of Operation
Continuous Operation
Equipment not suitable for use in the presence of flammable anesthetic mixture
with air, oxygen or nitrous oxide.
1.1.4. Product Compliance
The 3880 Patient Monitor is classified in the following categories for compliance:
This equipment is RoHS and WEEE compliant.
This equipment is suitable for connection to public mains as defined in CISPR 11.
This Monitor conforms to general safety standard for medical devices to IEC 60601-1.
This Monitor conforms to EMC safety standard to IEC 60601-1-2.
This Monitor conforms to usability safety standard for medical devices to IEC 60601-1-6
and IEC 62366.
Software is developed in accordance with IEC 60601-1-4 and IEC 62304.
The application of risk management analysis to medical device conforms to ISO 14971.
The SpO
2
Parameter conforms to IEC 80601-2-61.
The TEMP parameter conforms to IEC 80601-2-56.
The CO
2
parameter conforms to IEC 80601-2-55.
This Monitor conforms to particular safety standard for multifunction patient monitoring
equipment to IEC 60601-2-49.
The ECG parameter conforms to IEC 60601-2-27, ANSI/AAMI EC13.
The NIBP parameter conforms to IEC 80601-2-30
The alarm systems of the Monitor conform to IEC 60601-1-8.
Radio Compliance
INDUSTRY CANADA COMPLIANCE STATEMENT:
This device complies with Industry Canada licenseexempt RSS standard(s). Operation
is subject to the following two conditions: (1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may cause
undesired operation of the device.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux
appareils radio exempts de licence. L'exploitation est autorisée aux deux
conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2)
l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si
le brouillage est susceptible d'en compromettre le fonctionnement.