Electronic pen injector (TopPen I)

Content on this page summarizes the instructions-for-use style documentation for the reusable electronic pen packaged with Pegpesen^® cartridge presentations in China. Always follow the booklet shipped with your device.

Identity & registration (IFU excerpt)

• Device: Electronic pen injector (TopPen I)
• Registration (China, IFU): Fujian medical device registration number as printed in the current IFU (verify on your unit)
• Holder / manufacturer: Xiamen Amoytop Biotech Co., Ltd.; contracted manufacturing noted for electronics assembly per IFU.

Intended use

The pen is a reusable electromechanical injector used with Amoytop prefilled drug presentations for subcutaneous injection. Pen hardware does not contact drug solution directly; only the disposable needle and prefilled assembly touch medication paths.

Kit contents (IFU)

• Electronic pen injector ×1
• Instructions ×1
• Charging cable ×1
• Carrying pouch ×1
• Warranty card ×1

Needles and drug cartridges are supplied separately per drug packaging.

Dose performance

Stated injection accuracy in the IFU: ≤ ±8% under defined operating conditions.

Functional features

• Voice prompts for sequence steps (install cartridge, orientation for priming, injection, end-of-dose cues).
• Touch-activated injection after the skin collar is fully compressed—automatically controlling injection speed once “pressed to depth.”
• On-device log of recent injections (IFU: up to 30 records viewable on the pen).
• Error detection with audible/visual alerts and fault handling guidance in the manual.
• Sleep / power management to conserve battery after completed injections.

Workflow outline

1. Charge fully before first use (USB Type‑C); calibrate device time.
2. Pair with the companion mobile workflow via Bluetooth (see Digital page).
3. Install the prefilled cartridge per screen + voice guidance.
4. Confirm dose (device reads drug information; adjustable-dose SKUs per protocol).
5. Remove cartridge cap; run automated priming with pen oriented as directed.
6. Disinfect skin; press collar vertically to skin until “pressed to depth”; hold through countdown.
7. Dispose of cartridge/needle as sharps/biomedical waste; recap pen body.

Safety reminders

• Do not share pens between patients.
• Young children require trained adults to inject.
• Do not inject while charging.
• Single-use cartridges—avoid partial attempts without following IFU rescue steps.

Pairing, cybersecurity, and software versioning for the mini program are described in the IFU chapter on WeChat—see Digital care.