Product Manual

Indications for Use

Declaration of Conformity with FCC and Canadian Ministry of

Health Rules for Electromagnetic Compatibility

• Nonin Medical, Inc., of 13700 1st Avenue North, Plymouth, Minnesota, 55441, declares

under its sole responsibility that Model 3150, WristOx

Pulse Oximeter, to which this

declaration relates, 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.

• Ministry of Health (Canada), Safety Code 6: standards include a substantial safety margin

designed to ensure the safety of all persons, regardless of age and health. The exposure

standard for wireless mobile phones employs a unit of measurement known as the Specific

Absorption Rate, or SAR. The SAR limit set by the FCC is 1.6 W/kg.

NCC

警語低功率電波輻射性電機管理辦法第十二條經型式認證合格之低功率射頻電機，非經許可，公

司、商號或使用者均不得擅自變更頻率、加大功率或變更原設計之特性及功能。第十四條低功率

射頻電機之使用不得影響飛航安全及干擾合法通信；經發現有干擾現象時，應立即停用，並改善

至無干擾時方得繼續使用。前項合法通信，指依電信規定作業之無線電信。低功率射頻電機須忍

受合法通信或工業、科學及醫療用電波輻射性電機設備之干擾

在 5.25-5.35 秭赫頻帶?操作之無線資訊傳輸設備，限於室?使用。

Verify all visible indicators appear during the start-up (initialization) sequence. If any indicator does not appear,

do not use the device. Contact Nonin Technical Service for assistance.

Portable and mobile RF communications equipment can affect medical electrical equipment.

Batteries may leak or explode if used or disposed of improperly. Remove batteries if the device will be stored for

more than 30 days. Do not use different types of batteries at the same time. Do not mix fully charged and

partially charged batteries at the same time. These actions may cause the batteries to leak.

To avoid the risk of confusing or misinterpreting patient data when transmitting data via Bluetooth, verify the

device is paired with the correct display unit.

The pulse oximeter may not work when circulation is reduced. Warm or rub the finger or reposition the sensor.

A functional tester cannot be used to assess the accuracy of the oximeter or sensor.

Do not fasten the device too tightly around the patient’s wrist. Inaccurate readings and patient discomfort could

result.

If the WristOx

Model 3150 is being used with wireless communication, use the device within its designated

range of approximately 100 meters (spherical radius). Moving outside this range may cause missing or lost data.

Failure of a network data coupling (serial cable/connectors/wireless connections) will result in loss of data

transfer.

Radios and cell phones or similar devices can affect the equipment and must be kept at least 2 meters (6.5 feet)

away from equipment.

Cautions (Continued)