Important Safety Information

ADAPET PET CGM — Important Safety Information

Full indications, contraindications, warnings, precautions, storage, EMC & symbols.

CAUTION (U.S. Federal Law) Federal law restricts this device to sale by or on the order of a physician/veterinarian.

Indications for Use

The Adapet Pet CGM system is intended for continuous (or periodic) monitoring of interstitial fluid glucose levels for the management of diabetes in cats and dogs aged 2 years and older. The system provides real-time glucose values and trends and can issue alerts when values cross preset thresholds. Not for human use.

Important: CGM readings should not be used as the sole basis for diagnosis or for initiating/adjusting therapy without clinical judgment.

Compatibility

  • Sensor wear duration: up to 9 days.
  • Age: 2+ years.
  • Phone/App: Ensure your smartphone and operating system are compatible and notifications are enabled.
  • Operating system: 1. Android 5.0 and compatible version 2. iOS13 and compatible version

Contraindications

  • Remove all components before diathermy treatment (high-frequency electrical heat).
  • Sensors must not be used with automated insulin dosing systems.
  • Remove the sensor before MRI or CT scans.
  • Do not insert at sites with severe skin conditions (scalds, burns, sunburns, wounds, ulcers, surgical scars).
  • Use with caution in pets at risk of bleeding or with known allergies to disinfectants or medical tapes; consult a veterinarian.

Warnings

  • WARNING Do not ignore symptoms of hypoglycemia or hyperglycemia. If readings do not match how the pet appears, confirm with a blood glucose meter.
  • WARNING Access to a blood glucose monitoring system is required; a meter is not provided with the app.
  • WARNING Choking hazard — system includes small parts. Keep out of reach of children and pets.

Cautions & Precautions

  • Review the User’s Manual and follow all instructions to avoid missing severe glucose events.
  • Hygiene: follow aseptic techniques during application to reduce infection risk.
  • Pets may dislodge the device by biting/scratching or vigorous activity. Protect the site; avoid impacts and snagging on doorways, clothing, or ground rolling.
  • During rapid glucose change (>0.1 mmol/L per minute), interstitial glucose may lag behind blood glucose. Confirm suspected lows/highs with a meter.
  • If notable skin irritation occurs under or around the sensor, discontinue use and consult a veterinarian.
  • The system’s performance has not been evaluated in pregnant animals, animals on dialysis, or animals <1 year old.
  • Do not modify any component. The sensor, transmitter and applicator are single-use items.
  • Sensors and transmitter are water-resistant to IPX7 (freshwater, ≤1 m depth, ≤30 minutes). Do not use in seawater or beyond the rating.

App & Sensor Use

  • Verify phone compatibility and enable alarms/notifications.
  • Keep Bluetooth and (where required) location services enabled for continuous data transmission.
  • After application, promptly reinstall protective covers as instructed and dispose of the applicator per local sharps rules.

MRI/CT/Diathermy Safety

Remove the sensor and transmitter before MRI, CT, or diathermy procedures. Sensors may cause MRI artifacts; normal function typically resumes within ~1 hour after MRI when a new sensor is applied. Effects of these procedures on performance have not been fully evaluated.

Interfering Substances

  • A1 Sensor: Vitamin C > 500 mg/day may affect readings.
  • Tested non-interfering levels: ascorbic acid 1 mg/dL, acetaminophen 20 mg/dL, ibuprofen 50 mg/dL, aspirin 60 mg/dL showed no significant interference.

Storage & Environmental Conditions

Operating

  • Temperature: 41°F to 104°F (5°C–40°C)
  • Relative humidity: 10%–90% (non-condensing)
  • Atmospheric pressure: 70–104 kPa
  • Water resistance: IPX7

Storage / Transportation

  • Temperature: 35.6°F to 86°F (2°C–30°C)
  • Relative humidity: 10%–90% (non-condensing)
  • Shelf life: see label; typical 18 months.

How It Works

This real-time, calibration-free CGM uses a flexible sensor with glucose oxidase. The enzyme reaction in interstitial fluid generates an electrical current proportional to glucose concentration. Data are transmitted by the transmitter to the app/web portal where glucose values and trends are displayed.

Structure & Composition

The system consists of four parts: (1) sensor assembly, (2) transmitter assembly, (3) needle guide/applicator assembly, and (4) blood-glucose management software (release V1).

Sterility: the sensor assembly and the needle guide are sterile (radiation sterilization). Remaining parts of the applicator and the transmitter are non-sterile. Single-use only.

Maintenance & Disposal

Maintenance

  • The system has no user-serviceable parts. If needed, gently wipe the transmitter exterior with medical alcohol wipes and air-dry.
  • In case of fault, return to the manufacturer. Third-party repairs are not permitted.

Disposal

  • Follow local regulations for electronics, batteries, sharps, and items exposed to bodily fluids.
  • Do not discard sensors via municipal waste where prohibited (e.g., EU WEEE Directive 2012/19/EU — separate collection required).
  • Before disposing of the needle guide, reinstall the upper cover until it clicks into place; dispose at designated sharps collection sites.

Common Problems & Solutions

Problem Possible Cause Countermeasures
Transmitter not attached to skin Dust/oil/hair/sweat at site 1) Remove and reapply sensor/transmitter.
2) Shave with a 40+ blade; clean with soap/water; dry thoroughly.
3) Follow the application instructions precisely.
Skin irritation at site Rubbing from clothing or accessories; adhesive sensitivity Ensure nothing rubs the site. If irritation persists at adhesive, consult a veterinarian.
App running but no glucose data Bluetooth disconnected; location/GPS disabled; weak signal Reconnect Bluetooth, enable GPS if required, or move to a stronger-signal area.
Accuracy concerns First hours of wear; rapid glucose changes; sensor dislodged Allow warm-up; confirm during rapid rise/fall with meter; check sensor is secure/not bitten or pushed out by fur.

Electromagnetic Compatibility (EMC)

Emissions (Overview)
Emissions Test (GB/IEC) Level Guideline
RF Emission (GB 4824) Group 1 Uses RF energy only for internal function; low emission and little interference risk.
RF Emission (GB 4824) Class B Suitable for all establishments including domestic environments.
Immunity — ESD & Power (Excerpt)
Immunity Test IEC 60601 Test Level Conforms Environment Guideline
Electrostatic discharge (GB/T 17626.2) ±6 kV contact, ±8 kV air ±8 kV air Use wood/concrete/tile flooring; if synthetic, RH ≥30%.
Power-freq. magnetic field (GB/T 17626.8) 3 A/m 3 A/m Typical commercial/hospital environment.

Active medical devices require special EMC precautions. Avoid stacking or close proximity use with other devices unless verified for normal operation.

RF Immunity & Recommended Separation Distance

Portable and mobile RF communications equipment can affect the system. Keep transmitters at or beyond the distances calculated by:

  • d = 1.2√P for 150 kHz–800 MHz
  • d = 2.3√P for 800 MHz–2.5 GHz
Rated Power P (W) 150 kHz–80 MHz 80–800 MHz 800 MHz–2.5 GHz
0.01 0.12 m 0.12 m 0.23 m
0.1 0.38 m 0.38 m 0.73 m
1 1.2 m 1.2 m 2.3 m
10 3.8 m 3.8 m 7.3 m
100 12 m 12 m 23 m

Field strengths from fixed transmitters should be measured on-site and be below the applicable compliance levels. Interference may occur near equipment marked with RF symbols.

Basic EMC performance: System operates normally, communicates with the app, and does not crash.

RoHS Description

All listed components meet GB/T 26572 limits for hazardous substances in homogeneous materials.

Component Pb Hg Cd Cr(VI) PBB PBDE
Printed circuit board ○ ○ ○ ○ ○ ○
Electronic components ○ ○ ○ ○ ○ ○
Battery ○ ○ ○ ○ ○ ○
Housing ○ ○ ○ ○ ○ ○
Sensor ○ ○ ○ ○ ○ ○
Packing ○ ○ ○ ○ ○ ○

Legend: ○ = below limit per GB/T 26572. Components marked × (if any) exceed limits for at least one homogeneous material due to current technical constraints and will be improved as technology advances.

Interpretation of Symbols

  • Manufacturer
  • Production date / Lot code / Serial number
  • Validity / Expiry
  • Temperature limit / Humidity limit
  • Keep dry / Keep away from rain
  • Fragile / This way up / Stacking limit (layers & mass)
  • Non-ionizing radiation / Radiation sterilization
  • BF type applied part
  • Do not use if package is damaged
  • Single-use
  • Unsafe for MRI
  • Recyclable package / Dispose per local regulations
  • Restricted use of hazardous substances (EEE)
  • CMIIT ID (radio approval) / Bluetooth® identifier
  • IP rating example: IP27 = solids ≥12.5 mm protected (2) and water ingress protection level 7
Notes

Symbols shown on packaging/labels indicate handling, safety and regulatory information. Refer to the User’s Manual for full icon graphics.