Electromagnetic Compatibility (EMC)
The device is intended for use in the electromagnetic environment specified below. Given the
device's electromagnetic emissions and immunity characteristics, the customer or user should
assure that the device is used within such an environment. The following information is
mandated by IEC 60601‐1‐2, the international standard for the electromagnetic compatibility
(EMC) of medical electrical equipment.
INDUSTRY CANADA STATEMENT
This device complies with Industry Canada license‐exempt 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.
FCC COMPLIANCE STATEMENT
Changes or modifications not expressly approved could void your authority to use this equipment
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
The use of accessories, transducers and cables other than those specified in the accessory list
accompanying this Instructions for Use (with the exception of transducers and cables sold by
Invivo (Royal Philips) for the equipment or system as replacement parts for internal
components) will result in increased emissions or decreased immunity of the equipment or
1‐8 Important Information Expression MR400 Instructions for Use
Frequency Range: 2402–2482 MHz
Modulation Type: GFSK
WPU EIRP: 4.2 dBm (peak)
wECG and wSpO2 EIRP: 0 dBm (peak)