Questions about blood oxygen and pulse rate are answered in our FAQ.

Risks and Benefits

Before using any medical device, it is important to consult your physician and weigh the risks and benefits. See the Benefits and Risks of SilverKin below.

Risks

• Inappropriate Use or Misuse of the Tempo: The Tempo is not intended for diagnostic applications and cannot independently guide treatment decisions. Do not use device data as the sole basis for clinical diagnosis. Always consult a qualified clinician if you / device wearer are not feeling well or if physiological trends shown in the SilverKin app are concerning.
• Skin irritation: As with any item worn against the skin, there is a risk of irritation, pressure injury, or general discomfort. Check the skin under the Tempo regularly.
• Choking hazard: The battery and other small, detachable parts may cause choking or injury if swallowed. Keep loose batteries and detachable parts out of reach of children and people with cognitive impairment or dementia who may place objects in their mouth or may not be able to safely handle these parts.
• Electrical hazard: With any electrical device, there is a risk of electrical hazard. This risk is reduced by design and testing. Use only SilverKin-supplied batteries and chargers.

Benefits

• SilverKin facilitates intermittent, passive collection of SpO₂ and Pulse Rate data without invasive procedures.

Use of Pulse Oximeters and their Limitations

Pulse oximeters measure blood oxygen saturation (SpO₂) based on how light passes through tissue. The accuracy of SpO₂ readings depends on how well light is able to pass through the tissue.

Limitations

The following is a list of things that can be controlled to improve the consistency of the Tempo Wearer’s SpO₂ reading.

• Avoid direct exposure to high ambient light levels, including direct sunlight.
• Reduce excessive movement
• Warm your hands to improve circulation.
• Avoid use on the same arm with an inflated blood pressure cuff
• Keep the Tempo away from other electrical equipment that may cause readings to be affected (e.g., microwaves, strong radio transmitters).

The following is a list of things that can impact the SpO₂ reading that you should be aware of:

• Thickness of wrist skin or tattoos on the wrist directly under the device.
• Health conditions affecting how oxygen is carried in your blood (e.g., sickle cell, severe anemia).
• Poor blood circulation.
• Presence of substances in the blood that affect the ability of the blood to carry oxygen (e.g., elevated carbon monoxide levels in your blood, recent tobacco use).
• Age and medical history.

Safety Information

Warnings and Cautions

This section groups the warnings and precautions you need before you set up or use SilverKin. Read this section completely before you open the box.

General Safety Warnings

• Pediatric Use: The SilverKin System has not been validated for use in a pediatric population. Do not use Tempo on people younger than 22 years of age.
• Device Damage: Avoid using the Tempo or batteries if damage is visible or suspected, as exposed electrical circuits may pose a risk of harm.
• No Modifications: Do not adjust, repair, open, disassemble, or modify the Tempo and batteries. Modifications may cause injury and/or inaccurate readings.
• Flammable Environments: Do not use the Tempo and batteries in the presence of flammable anesthetics, oxygen-enriched atmospheres, or nitrous oxide. There is a risk of fire.

CAUTIONS

• Failure to insert a charged battery in Tempo promptly after a Low Battery alert may result in the device shutting down.
• To ensure transmission of SpO₂ and PR data to the SilverKin system, check that the Tempo is connected to the internet. The data from Tempo will not reach the SilverKin app if the device is not connected to the internet. Restore the internet connection within 24 hours to prevent loss of data.

Directions for Use

Warnings

• Fit Snugly: The Tempo is worn on the wrist. Fit the strap snugly but not tightly. Use the two-finger rule: you should be able to slide two fingers between the strap and the Wearer’s wrist. A strap that is too tight may cause pressure injury; a strap that is too loose may reduce measurement accuracy.
• Inspect Periodically: Check the Wearer’s skin under the device periodically while it is being worn, in addition to checking the skin before application to avoid use of the Tempo over reddened or irritated skin.
• Limit Excessive Movement: The Tempo will not transmit SpO₂ and pulse rate measurements during times of excessive wrist movement.
• Poor Circulation (Low Perfusion): The Tempo’s accuracy has not been established in Wearers with low peripheral perfusion (e.g., due to peripheral vascular disease, low blood pressure, or certain medications).
• Keep the Application Site (Wrist) Warm: Cold skin under the device reduces blood flow at the monitoring site and can cause inaccurate, unreliable, or missing SpO₂ and pulse rate readings. Keep the wearer’s wrist on which the device is worn at a normal temperature and avoid prolonged cold exposure.

Cautions

Check the Skin Before Placing the Tempo on the wrist: Inspect the wrist every time before placing the Tempo on the wrist.

• Do not place over broken, irritated, or reddened skin.
  • Do not place over macerated (softened, waterlogged) skin.
  • Avoid placing the optical sensor directly over tattooed skin. Tattoos can compromise the accuracy and reliability of SpO₂ and Pulse Rate measurements.
• If the skin on one wrist is compromised, place the Tempo on the other wrist only if the skin there is intact.
• Keep the Application Site (Wrist) Dry: Do not place the Tempo on the Wearer’s wrist until the Wearer’s wrist is completely dry. Moisture trapped under the strap can cause skin irritation or breakdown.

Setup and Charging

Cautions

• Use only the SilverKin-supplied power adapter, cable, and charging dock. A different charger may impair device function or create a safety hazard.
• Always charge Tempo batteries when not in use so a charged battery is ready when you need it.
• Failure to insert a charged battery in Tempo promptly after a Low Battery alert may result in the device shutting down.
• Batteries lose capacity with age. The length of time a battery lasts before it reads “low” will change over time.

Interpreting SpO₂ and Pulse Rate Data

Warnings

• Not for Diagnosis: The Tempo is not intended for diagnostic use. Do not use SpO₂ or pulse rate data from the Tempo as the sole basis for a clinical diagnosis or treatment decision. Contact a qualified healthcare professional if you have questions or concerns about the readings.
• Do Not Adjust Treatment Based on SilverKin Data Alone: Do not Adjust or change medication, oxygen therapy, or other treatment based on SilverKin data alone. Contact a healthcare professional before making any change to care based on SpO₂ or pulse rate measurements or trends.
• Review Trends: Review SpO₂ and pulse rate measurements together with the Wearer’s previous measurements and usual trend. Do not rely on a single SilverKin measurement alone when deciding whether to contact a healthcare professional.
• SpO₂ Typical Ranges: Blood oxygen saturation (SpO₂) is the percentage of blood that is saturated with oxygen. In a medical setting, a typical SpO₂ level is 95–100%. Normal values can be lower in people with lung disease, in older adults, or at high altitude. These values are provided for general reference only and do not diagnose or rule out any condition.^1,2
• Pulse Rate Typical Ranges: A normal resting pulse rate for most adults is between 60 and 100 beats per minute (bpm). It may be lower during sleep and higher during physical activity.³
• When to Contact a Healthcare Provider: Contact a healthcare provider if the Wearer’s SpO₂ or pulse rate shows a sustained or unexpected change from their usual trend, or if the Wearer has symptoms or other signs of concern, such as shortness of breath, dizziness, confusion, or bluish discoloration of the lips or fingertips, even if SpO₂ and pulse rate values appear normal. Since the Tempo does not provide alerts, do not delay seeking medical attention.
• No Alarms or Real-Time Alerts: Tempo and SilverKin applications do not provide alarms or real-time alerts for SpO₂ or pulse rate. Do not rely on the SilverKin System for emergency response, continuous monitoring, or critical care. Do not wait for the device or application to alert you before seeking medical attention – neither the device nor the app provides alerts for SpO₂ or pulse rate.
• Skin Pigmentation: Differences in skin pigmentation may affect pulse oximeter performance and the accuracy of SpO₂ and Pulse Rate readings, particularly at low oxygen levels. Pulse oximeter readings may be less accurate in some individuals with darker skin pigmentation.

Cautions

• If a Reading Does Not Appear: Tempo will not transmit measurements when there is excessive motion. Check that the Tempo is fitted snugly, the Wearer’s wrist is warm, and the Wearer is relatively still during measurement, then allow the device to retry at the next scheduled measurement. If SpO₂ or pulse rate data is consistently unavailable, refer to Troubleshooting.
• Optical, pleth-based measurements (e.g., SpO₂ and PR) can be affected by the following:
  • Incorrect Tempo placement or securement (e.g., too loose, too tight).
  • Blood pressure cuff inflated or constriction of the same arm.
  • Intravascular dyes such as indocyanine green or methylene blue.
  • Arterial catheter, Venous congestion
  • Loss of pulsatile signal
  • Moisture, birthmarks, skin discoloration, tattoos, henna, or foreign objects in the light path.
  • Elevated levels of bilirubin
  • Physiological conditions that can significantly shift the oxygen dissociation curve.
  • Abnormal venous pulsations (e.g., tricuspid valve regurgitation, Trendelenburg position).
  • Abnormal pulse rhythms due to physiological conditions or induced through external factors (e.g., cardiac arrhythmias, intra-aortic balloon, etc.).
• No or inaccurate SpO₂ readings may additionally be caused by:
  • Elevated levels of COHb and/or MetHb. Note: High levels of COHb or MetHb may occur with a seemingly normal SpO₂.
  • Severe anemia.
  • Very low arterial perfusion.
  • Excessive motion.
  • Hemoglobinopathies and synthesis disorders (e.g., thalassemias, Hb s, Hb c, sickle cell).
  • Peripheral vascular disease.
  • EMI radiation interference

Magnetic Resonance (MR) Safety Information

• The Tempo has not been evaluated for safety in the MR environment. It has not been tested for heating or unwanted movement in the MR environment. The safety of Tempo in the MR environment is unknown. Performing an MR exam on a person who has this medical device may result in injury or device malfunction.
• Remove the Tempo from the wrist before any transport for an MRI procedure.

Cleaning and Service

Cautions

• Clean the device only with the solution listed in Cleaning and Maintenance. Never completely soak the device in any disinfectant.
• Follow your local laws when disposing of the device, accessories, or batteries. Do not incinerate the device or the battery, or place either in a trash compactor. Do not puncture the battery.

Compliance Warnings

Warnings

• Do not attempt to burn, incinerate, or destroy the Tempo or its batteries. The device contains a lithium-ion battery that poses a fire/explosion risk if exposed to flame and should be properly disposed of according to local laws and regulations.

Cautions

• Comply with local laws when disposing of the device, accessories, and batteries.
• In accordance with international telecommunication requirements, the frequency band of 2.4 GHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems.
• SilverKin System has been tested and found to comply with the Class B limits for medical devices according to EN 60601-1-2: 2015. These limits are designed to provide reasonable protection against harmful interference in all establishments, including domestic establishments.
• 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 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.
  • Consult the dealer or an experienced radio/TV technician for help.
• This equipment has been tested and found to comply with the Class B limits for medical devices according to the IEC 60601-1-2:2014. These limits are designed to provide reasonable protection against harmful interference in all establishments, including domestic establishments.

Sources

1. https://www.fda.gov/consumers/consumer-updates/pulse-oximeter-basics
2. MedlinePlus, U.S. National Library of Medicine, Pulse Oximetry
3. https://www.heart.org/en/health-topics/high-blood-pressure/the-facts-about-high-blood-pressure/all-about-heart-rate-pulse

Questions? Call us at 1-800-608-7188 or email orders@silverkin.com.