Help Center

The Welltot Continuous Temperature Sensor is used to measure the human body temperature on the skin. The device is for all ages.

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The Welltot Continuous Temperature Monitor is not a clinical grade thermometer.

Failure to use the Welltot Continuous Temperature Monitor according to the instructions for use available at https://www.welltot.com/instructions and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in inaccurate readings. Seek medical advice and attention when appropriate, including for any medical emergency.

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• Do not use as a clinical grade thermometer. This device is not a clinical grade thermometer.
• Never user the thermometer for purposes other than those it has been intended for.
• Do not bend or bite the sensor
• Do not use the sensor if there are signs of damage. If damaged, do not attempt a repair and dispose immediately.
• Do not expose the thermometer to temperature extremes: (below -13°F/ -25°C or over 131°F/55°C) or excessive humidity (>95% RH).
• Allow the sensor to warm up for 20 minutes after applying to the skin.
• Use a password on your smartphone to protect your information.
• High, prolonged fever requires medical attention. Be sure to contact your physician.
• The thermometer is water resistant, not waterproof. Never dip the sensor into water or other liquids. Do not boil the sensor.
• Keep out of reach of young children and elderly when not in use.
• If any component becomes loose, detached, or broken small parts may represent a chocking hazard. Dispose immediately.
• Keep out of reach of pets.
• Inspect the system prior to use for any defects.
• Keep mobile device within 30 feet of the sensor to maintain connection. Communication range will vary depending on obstacles (person, metal, wall, etc.) or electromagnetic environment.
• When using alarms, ensure the mobile device using alarms is not on silent mode and the volume turned up.
• When using alarms, pay attention to all alarms from the mobile device as vibrations and alerts may not be different than other alerts for the mobile device.
• Do not install the app on a jailbroken or rooted smart device.
• Enable notifications for the app on the smart device so that you will receive notifications from the app.
• Do not modify any component of the system.
• Only use components designed for use with the system.
• Wear or remove headphones from the mobile device. Alerts will not be audible through the speaker when headphones are connected to their mobile device.
• WARNING: Children under the age of 3 should wear a onsie or similar clothing to prevent the strap from wrapping around a child's neck.
• WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to the sensor. Otherwise, degradation of the performance of this equipment could result.
• WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in degradation of performance. If such use is necessary, this equipment should be observed to verify that they are operating normally Power line magnetic fields (in excess of should be kept at a distance to reduce the likelihood of interference.
• WARNING: Keep device away from sources of high levels of pline magfields (in excess of 30A/m) to reduce the likelihood of interference. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this device.
• WARNING: Remove the sensor before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high -frequency electrical heat (diathermy) treatment.

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• Designed for a single person use
• Temperature reading multiple times per hour.
• Meets ASTM standards for electronic thermometer for intermittent determination fo patient temperature.
• Connects to API via a gateway, so that any health or medical software may use the data, such as the Welltot app.
• Designed for comfort with adhesive and chest strap method of attachment.
• Designed for all ages.
• Water resistant with IPX 67 rating.
• This device uses Bluetooth Low Energy version 5 to communicate with devices.

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Putting the sensor On

1. Peel the backing off the adhesive patch and stick it to the back of the adhesive.
2. Peel the other side of the adhesive patch off and stick this to either the center of the chest or side of chest (under the arm).

Note: After wearing the chest strap, allow the sensor to warm up for 20 minutes against the skin.

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1. Pull up the small velcro tabs on the chest strap.
2. Thread the tabs through the holes in the senor and secure the sensor to the strap. Ensure the sensor contact is exposed.
3. Adjust the length of the strap to fit snug around the chest.
4. Attach the chest strap where the sensor contact is against the skin, either in the center of the chest or side of the chest (under the arm).

Note: After wearing the chest strap, allow the sensor to warm up for 20 minutes against the skin.

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Store the sensor in a cool, dry location between uses.

Long Term Storage Ranges

Temperature: 14°F to 86°F (-10°C to 30°C)

Humidity: 0 - 95%RH (non-condensing)

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There are a few items required to use this product:

• Smart device, either running Apple iOS or Android operating system
• Bluetooth compatible smart device
• Internet connection
• AffirmXH or Welltot account.

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Removing the sensor when using adheasive

When the edges of the adheasive start to come lose (typically after 4 days), peel off the remaining adhesive and reapply a new piece of adhesive. Alcohol may be needed to help remove the old adhesive.

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When the system is no longer usable, please dispose the sensor at an electronic recycling facility in accordance with local electronic waste regulations. The sensor contains a non-rechargeable single-use coin cell battery.

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If you need help with your Welltot product, have questions, or have problems, please email us at support@welltot.com or visit us online at www.welltot.com/support

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Skin Temperature Accuracy (Maximum lab error)

The skin temperature accuracy is based on a recognized standard for measuring thermometer accuracy. The temperature compares the reading from the device to a clinically calibrated water bath.

±0.2°C between 95.0°F - 107.6°F (36°C - 39°C)

±0.6°C outside 95.0°F - 107.6°F (36°C - 39°C)

Temperature Resolution

Resolution: 0.1°F/ 0.1°C

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This product conforms to the following standards

ASTM Standard E 1965-98:2009 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
IEC/EN 60601-1-2: 2014 «Medical electrical equipment» – Part 1-2: General requirements for safety - electromagnetic disturbances and electromagnetic emissions

IEC 60601-1-11: 2010 «Medical electrical equipment» - Part 1-11: General requirements for basic safety and essential performance - Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

FCC Note: 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 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, which could theoretically cause harmful interference to radio communications. 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: increase the separation between the equipment and receiver, consult the dealer or an experienced radio/TV technician for help, or contact customer support.

The equipment is suitable for use in domestic establishments and is tested to CISPR emissions Class B Group 1 as well as home healthcare immunity criteria found in IEC 60601-1-2 Table 4, 6, and Table 9. During the IEC 60601-1-2 immunity tests performed the thermometer will accurately measure temperature or display an error.

This product utilizes Bluetooth Low Energy (BLE), which uses the 2.4 GHz ISM band. BLE operates between 2.402 and 2.480 GHz. This product transmits less than 0 dBm effective radiated power.

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Manufactured By
AffirmXH, Inc.
1005 Tahoe Glen Place
Cary, NC 27513
Customer Support: support@welltot.com

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AffirmXH, Inc warrants this product against any defects that are due to faulty material or workmanship for a period of one year from the original date of consumer purchase or receipt as a gift. This warranty applies when used for normal household use in accordance with the Instructions for Use and excludes damage to the product resulting from accident or misuse. This product is not warrantied when used in a professional environment.

In no event shall AffirmXH, Inc be liable for any special, incidental, indirect, or consequential damages in connection with the purchase or use of this product or costs over the original cost of the product.

If the product should not perform to specifications within the warranty period, please contact Customer Support.

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Consult instructions for use

Storage temperature limitation

Humidity limitation

Serial number

Manufacturer batch code

Catalogue number

Non-sterile

Do not use if product is broken, damaged, or open

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Operation Time

The sensor will have 6 months of use, if started by no more than 12 months after manufacturer date.

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A trademark can be a word, phrase, symbol, or design that distinguishes the source of the goods or services. Also, as trade dress, it can be the appearance of a product or its packaging, including size, shape, color, texture, graphics, and appearance (e.g, retail store or website).

The following is a non-exhaustive list of AffirmXH trademarks and service marks.

When using the marks in publications that will be distributed only in the United States, include the appropriate ™, ℠, or ® symbol on first use. For publications that will be distributed outside the United States, do not include trademark symbols. Instead use the appropriate trademark attribution notice, for example: Welltot are trademarks of AffirmXH, Inc., registered in the U.S. and other countries and regions.

The list also includes a suggested generic term for each trademark in parenthesis. For all publications, include an appropriate generic term after the trademark the first time it appears. Thereafter, the generic term should appear frequently with the trademark. (These generic terms are only suggestions, and there may be other words that are equally appropriate.)

Trademarks are adjectives, and should not be made into verbs or made plural or possessive.

The absence of a product or service name or logo from this list does not constitute a waiver of AffirmXH's trademark or other intellectual property rights concerning that name or logo.

• Welltot™ (Continuous Temperature Monitor)

SPECIAL AND LICENSED TRADEMARKS AND/OR COPYRIGHTS
Use the trademark notation shown here the first time the trademark is mentioned in text in U.S. publications. Include the credit line in all U.S and international publications in which the trademark is mentioned.

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The sensor has an IP67 rating. This means that the sensor is protected water submersion for 30 minutes between 15cm and 1m deep. It is also protected from dust.

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You can clean the sensor with an alcohol swap.

Note: Do not boil the sensor in water.

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