Roche Diagnostics UU18 User Manual

General information for installing
Handheld Base Module Version 4 (HBM4) User / Instruction Manual
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Warning for unauthorized modifications
Changes or modifications made to the equipment not expressivly approved by Roche Diagnostics may void the FCC / IC authorization to operate this equipment.
The radio transmitter equipped Handheld Base Module Version 4 (HBM4) can be installed in different end-use devices (hostreferred to as a host, host product, or host device) by manufacturer (Roche Diagnostics GmbH, Germany). A host product is required to comply with all applicable FCC equipment authorizations regulations, requirements and equipment functions not associated with the transmitter module portion. To ensure compliance with all non-transmitter functions, the host manufacturer is responsible for ensuring compliance witg the module(s) installed and fully operational.
OEM integrator must ensure that the end user manual may not contain any information about the way to install or remove the module from the final product.
Device specific distinctions
The module will be used in 2 different configurations, to meet the arrangement of device specific cable connections for further components (digital display, button and parameter specific measurement modules). The conducting paths are identical for each configuration, but the mechanical ports are getting installed device specific. This will ensure, that the WLAN functionality will not be affected due to different configurations.
FCC and IC compliance (english)
This device complies with Part 15 of the FCC Rules and with Industry Canada licence-exempt RSS standards. 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.
FCC and IC compliance (french)
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.
V1.3
Standard Data Rates IEEE 802.11b Modulation IEEE 802.11b
IEEE 802.11g
DSSS/CCK
802.11b/g
OFDM
1, 2, 5.5 and 11 Mbps
The module must be installed and used in strict accordance with the manufacturer's instructions as described in the user documentation that comes with the module.
Label Information
The information on the label and in the user manual is required to be incorporated in the manual of the final host device,. see 47 CFR15 requirements for more details (e.g. 15.19 / 15.21 / 15.101 / 15.105 / RSS-GEN / ICES)
Additional authorization requirements for the non­transmitter functions of the transmitter equipped HBM4 Module due to the intended use (IVD device) are required. The OEM integrator is responsible for ensuring that the after the moduile is installed and operational, the host continues to be compliant with the Part 15B unintentional radiator requirements.
The use of the transceiver module is authorized in mobile and stationary host devices taking into account the following conditions:
User Manual
The end user manual for the final host device operating with this transmitter must include operating instructions to satisfy RF exposure compliance requirements
The inforamtion on the label and in the user manual is required to be incorporated in the manual of the final host device,. see 47 CFR15 requirements for more details (e.g. 15.19 / 15.21 / 15.101 / 15.105 / RSS-GEN / ICES)
Additional label with the words 'Contains FCC ID: VO9UU18' and 'Contains IC:3100A-UU18' shall be applied and visible from the outside of the host device
Integrated antenna
When the final host product operating with this transmitter deviate from above, installation of this module into specific final hosts may require the submission of a Class II permissive change application containing data pertinent to RF Exposure, spurious emissions, ERP/EIRP, and host/module authentication, or new application if appropriate.
General information
The antenna of the module may not be removed, replaced nor modified. The antenna must not be co­located or operating in conjunction with any other antenna or transmitter. No additional antenna must be used
Radiofrequency radiation exposure Information
The radiated output power of the device is far below the FCC radio frequency exposure limits. Nevertheless, the device shall be used in such a manner that the potential for human contact during normal operation is minimized.
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance of 20 cm between the radiator and your body. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
V1.3
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