IVY BIOMEDICAL 001-0001 ECG Patient Monitor User Manual

001-0001 ECG Patient Monitor
User Manual

CURRENT REGULATORY CERTIFICATIONS

The 580076 holds current certifications in the following countries:

CERTIFIED ANTENNAS

MHz-2480 MHz)
001-0014| Laird Connectivity| PIFA| IPEX U.FL| 2 dBi (2400 MHz-2480 MHz)
001-0015| Laird Connectivity| FlexNotch| IPEX U.FL| 2 dBi (2400 MHz-2480 MHz)
001-0030| Laird Connectivity| PIFA| IPEX U.FL| 2 dBi (2400 MHz-2480 MHz)
N/A| Laird Connectivity| PCB printed| N/A| 0 dBi

Note: The OEM is free to choose another vendor’s antenna of like type and equal or lesser gain as an antenna appearing in the table and still maintain compliance. Reference  FCC Part 15.204(c)(4) for further information on this topic.
To reduce potential radio interference to other users, the antenna type and gain should be chosen so that the equivalent isotropic radiated power (EIRP) is not more than that permitted for successful communication.

FCC REGULATORY

Federal Communication Commission Interference Statement

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 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.

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.
This portable transmitter with its antenna complies with FCC/IC RF exposure limits for general population/ uncontrolled exposure.

FCC Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate 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.

IMPORTANT NOTE:
FCC Radiation Exposure Statement:

The product complies with the US portable RF exposure limit set forth for an uncontrolled environment and is safe for intended operation as described in this manual.
Further RF exposure reduction can be achieved if the product can be kept as far as possible from the user body or set the device to lower output power if such a function is available.
This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
This device is intended only for OEM integrators under the following condition:

1. The transmitter module may not be co-located with any other transmitter or antenna,

Since this module and its associated set of approved antennas have been certified as a Modular Radio, this allows the end-user to integrate this module into an end-product without the requirement of re-certifying the radio module. The module integrator is responsible for the unintentional conducted and radiated emissions and must verify that the integrated product is compliant with the rules associated with unintentional radiators. FCC also expects integrators to do spot checking of transmitter tests as necessary based upon KDB 996369 D04. The module integrator is also required to maintain an engineering record of the verification testing and declare on the product through proper labeling and marking that the device is compliant with these particular rules.

IMPORTANT NOTE
If this condition cannot be met (for example, certain laptop configurations or co-location with another transmitter), then the FCC authorization is no longer considered valid and the FCC ID cannot be used on the final product. In these circumstances, the OEM integrator is responsible for re-evaluating the end product (including the transmitter)  and obtaining a separate FCC authorization.

End Product Labeling
The final end product must be labeled in a visible area with the following: “Contains FCC ID:2A3IX-WGS100”.
Manual Information to the End-User
The OEM integrator has to be aware not to provide information to the end-user regarding how to install or remove this RF module in the user’s manual of the end product which integrates this module.
The end-user manual shall include all required regulatory information/warning as shown in this manual.

ISED (CANADA) REGULATORY

ISED Canada Statement

This device complies with Industry Canada’s license-exempt RSSs. 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.

Radiation Exposure Statement:
The product complies with the Canada portable RF exposure limit set forth for an uncontrolled environment and is safe for intended operation as described in this manual.  The minimum separation distance for portable use is limited to 15mm assuming the use of an antenna with 2dBi of gain. Further RF exposure reduction can be achieved if the product can be kept as far as possible from the user body or set the device to lower output power if such a function is available.

IMPORTANT NOTE:
In the event that these conditions cannot be met (for example certain laptop configurations or co-location with another transmitter), then the Canada authorization is no longer considered valid and the IC ID cannot be used on the final product. In these circumstances, the OEM integrator will be responsible for re-evaluating the end product (including the transmitter) and obtaining a separate Canada authorization.

End Product Labeling
The final end product must be labeled in a visible area with the following: “Contains IC: 27829-WGS100”.

Manual Information to the End-User
The OEM integrator has to be aware not to provide information to the end-user regarding how to install or remove this RF module in the user’s manual of the end product which integrates this module.
The end-user manual shall include all required regulatory information/warning as shown in this manual.

This radio transmitter IC: 27829-WGS100 has been approved by Innovation, Science, and Economic Development Canada to operate with the antenna types listed below, with the maximum permissible gain indicated. Antenna types not included in this list that have a gain greater than the maximum gain indicated for any type listed are strictly prohibited from use with this device.

MHz-2480 MHz)
001-0014| Laird Connectivity| PIFA| IPEX U.FL| 2 dBi (2400 MHz-2480 MHz)
001-0015| Laird Connectivity| FlexNotch| IPEX U.FL| 2 dBi (2400 MHz-2480 MHz)
001-0030| Laird Connectivity| PIFA| IPEX U.FL| 2 dBi (2400 MHz-2480 MHz)
N/A| Laird Connectivity| PCB printed| N/A| 0 dBi

ISED ICES-003 Issue 7 Compliance Declaration

This device was originally tested to the requirements of ICES-003 Issue 6, Information Technology Equipment (Including Digital Apparatus) — Limits and Methods of  Measurement; and evaluated to the updates published in ICES-003, Issue 7, Information Technology Equipment (Including Digital Apparatus). Based on this evaluation, this product continues to observe compliance with the requirements set forth by The Innovation, Science and Economic Development Canada (ISED) and complies with the updates published in ICES-003, Issue 7, Information Technology Equipment (Including Digital Apparatus).

Ivy Biomedical Systems, Inc. | 11 Business Park Drive | Branford, CT 06405
P 203.481.4183 | F 203.481.8734 | www.ivybiomedical.com

References

• Ivy Biomedical Systems, Inc. Welcome

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