Tempdrop Sensor Safety Information

Safety information for the battery

• Insert batteries as indicated inside the battery compartment.
• Dispose of batteries safely. Do not dispose of this product in a fire.
• The batteries inside may explode or leak.
• Never short-circuit the battery terminals.
• Use only batteries of the same or equivalent type, as recommended.
• Do not charge non-rechargeable batteries.
• Remove exhausted batteries promptly.
• The international standard IEC 60086-4:2019 considered the CR2032 battery as a swallowable battery type.

The Tempdrop labeling contains the symbols that are listed below:


Symbol (pictorgram)	Referring standard	Meaning
	ISO 7010-W001 IEC 60601-1	General warning sign. This safety sign cannot be used on its own and requires a supplementary sign to give further information about the hazard.
	Revised pictogram E in Table D1 of BS EN IEC 60086-4:2019 Primary batteries. Safety of lithium batteries.	KEEP OUT OF REACH OF CHILDREN. Should be used along with symbol ISO 7010-W001 and warning text: “KEEPOUTOFREACHOFCHILDREN Swallowing can lead to chemical burns, perforation of soft tissue, and death. Severe burns can occur within 2 hours of ingestion. Seek medical attention immediately”
	ISO 7000-3082 ISO 15322-1:2021	Manufacturer. This symbol shall be accompanied by the name and  address of the manufacturer adjacent to the symbol
	ISO 7000-0434A ISO 15223-1:2021	Caution. To indicate that caution is necessary when operating the device or control close to where the symbol is placed, or to indicate that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.
	ISO 7000-2497 ISO 15223-1:2021	Date of manufacture. Indicates the date when the medical device was  manufactured.
	ISO 7000-2607 ISO 15223-1:2021	Use-by date. Indicates the date after which the medical device is not to be used.
	ISO 7000-2492 ISO 15223-1:2021	Batch code. Indicates the manufacturer’s batch code so that the batch or lot can be identified.
	ISO 7000-2493 ISO 15223-1:2021	Catalogue number. Indicates the manufacturer’s catalog number so that  the medical device can be identified.
	ISO 7000-0624 ISO 15223-1:2021	Keep away from sunlight. Indicates a medical device  that needs protection from light sources.
	ISO 7000-0626 ISO 15223-1:2021	Keep dry. Indicates a medical device that needs to be protected from moisture.
	ISO 7000-0632 ISO 15223-1:2021	Temperature limit. Indicates the temperature limits to which the medical device can be safely exposed.
	ISO 7000-2620 ISO 15223-1:2021	Humidity limitation. Indicates the range of humidity to which the medical device can be safely exposed.
	ISO 7000-1641 ISO 15223-1:2021	Consult instructions for use or consult electronic instructions for use. Indicates the need for the user to consult the instructions for use (eIFU).
	EU Directive (2012/19/EU) on waste electrical and electronic Equipment (WEEE)	This symbol on the product or on its packaging indicates that this product should not be treated as household waste. Instead, it should be handed over to the applicable collection point for the recycling of electrical and electronic equipment. By ensuring this product is disposed of correctly, you will help prevent potential negative consequences for the environment and human health. The recycling of these materials will help to conserve natural.
	REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices	REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices
	ISO 15223-1:2021	Indicates the item is a medical device
	IEC 60417-5333 IEC 60601-1-11	Type BF applied part. Patient leakage current met the limits related to the home healthcare environment.
	ISO 15223-1:2021	Atmosphericpressurelimitation. Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
	ISO 15223-1:2021	Single patientmultiple use. Indicates a medical device that may be used multiple times (multiple procedures) on a single patient
	IEC 60529	Ingress Protection rating. 4 Protected against solid foreign objects of 1,0 mm ‡ and greater 2 Protected against vertically falling water drops when ENCLOSURE tilted up to 15º
	ISO 15223-1:2021	Authorized Representative in the European Community / European Union

Certification

Tempdrop was designed and tested to meet the applicable standards for Electrical Safety, Electromagnetic Compatibility, Sustainability, and other regulatory requirements. 

For questions related to the regulatory compliance of this product, contact: support@temp-drop.com

Federal Communications Commission (FCC) Statement

Labeling Requirements (FCC 15.19)

This device complies with Part 15 of 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. 

Radio Frequency Interference (RFI) (FCC 15.105)

This equipment has been tested and found to comply with the limits for Class B digital devices pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential environment. This equipment generates, uses, and can radiate radio frequency energy, and if not installed and used in accordance with the instruction manual, 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 and correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
•  Increase the separation between the equipment and the 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.

Modifications (FCC 15.21)

Changes or modifications to this equipment not expressly approved by Tempdrop Ltd may void the user’s authority to operate this equipment.

RF Exposure info (FCC 2.1093)

The device meets the exemption from the routine evaluation limits in section 4.3.1 of KDB 447498 D01. Users can obtain information on RF exposure and compliance on the FCC website.

Data protection

Sharing a sensor could lead to the transfer of personal data across user accounts. The Tempdrop sensor must be synced after each use via the app to clear personal data from the device. 

Skin sensitivity 

In rare cases, wearing the Tempdrop sensor may cause skin irritation. In the case of any irritation consult with your health care provider. 

Operating temperature limits

Tempdrop should be operated within the range of 41-104 degrees Farenhieght. Do not operate the sensor in temperatures outside this range.