Certification
PSTI Compliance
PSTI Statements of Compliance
Vulnerability Disclosure & Product Support Policy
Vulnerability Disclosure Policy.
Product Support
We provide support for any of our products capable of receiving security updates for at least 2 years from its first commercial launch.
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FCC Regulations
FCC ID: 2AEHI-5060442520035
Certification markings can be found inside the pump hub and in the instructions for Use.
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.
Changes or modifications not expressly approved by the party responsible for compliance could void the user‘s authority to operate the equipment.
Changes or modifications not expressly approved by the party responsible for compliance could void the user‘s authority to operate the equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
CE Marking - Radio Equipment Directive (RED)
"This device complies with EU’s Radio Equipment Directive 2014/53/EU (RED), the device’s declaration of conformity can be found here.
International Organization for Standardization (ISO)
This device is compliant with the biological evaluation of medical devices as set out in international organization for standardization (ISO).
Bluetooth Smart (Low Energy)
Bluetooth RF Output Power 0.2 dBm
Frequency band 2402-2480 MHz
FCC ID: 2AEHI-EL0115
Carry case
FCC ID: 2AEHI-EL0215
Certification markings can be found under the Elvie tail and inside the carry case.
FCC Regulations
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.
Changes or modifications not expressly approved by the party responsible for compliance could void the user‘s authority to operate the equipment.
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
CE
This device complies with EU’s Radio Equipment Directive 2014/53/EU (RED), the device’s declaration of conformity can be found here.
Bluetooth Smart (Low Energy)
Bluetooth RF Output Power 0.2 dBm
Frequency band 2402-2480 MHz
International Organization for Standardization (ISO)
This device is compliant with the biological evaluation of medical devices as set out in international organization for standardization (ISO).
FCC Regulations
FCC ID: 2AEHI-EB01
Certification markings can be found on the underside of the hub and in the instructions for Use.
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.
Changes or modifications not expressly approved by the party responsible for compliance could void the user‘s authority to operate the equipment.
Changes or modifications not expressly approved by the party responsible for compliance could void the user‘s authority to operate the equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
CE Marking - Radio Equipment Directive (RED)
This device complies with EU’s Radio Equipment Directive 2014/53/EU (RED), the device’s declaration of conformity can be found here .
UKCA Marking- The Radio Equipment Regulations 2017
This device complies with UK’s Radio Equipment Regulation 2017, the device’s declaration of conformity can be found here.
Bluetooth Smart (Low Energy)
Bluetooth RF Output Power 0.2 dBm
Frequency band 2402-2480 MHz
Biocompatibility
This device is compliant with the relevant requirements of ISO 10993 Biological evaluation of medical devices.
CE Marking - Radio Equipment Directive (RED)
This device complies with EU’s Radio Equipment Directive 2014/53/EU (RED), the device’s declaration of conformity can be found here .
CE Marking - Radio Equipment Directive (RED)
This device complies with EU’s Radio Equipment Directive 2014/53/EU (RED), the device’s declaration of conformity can be found here.
CE Marking
This device’s declaration of conformity can be found here.
CE Marking
This device’s declaration of conformity can be found here.
CE Marking
This device’s declaration of conformity can be found here.
CE Marking
This device's declaration of conformity can be found here.
CE Marking
This device declaration of conformity can be found here.
CE Marking
This device declaration of conformity can be found here.
CE Marking
This device declaration of conformity can be found here.