Lilly Ergo Pen II - Reusable, Cartridge insulin‑delivery pen
Feature Specification
Dose range: 1–60 units
Dose increment: 1 unit
Cartridge size: 3 mL (100 IU/mL)
Compatible insulin: Humalog®, Huminsulin®
Mechanism: Mechanical piston syringe
Needles: Standard detachable pen needles
Regulatory clearance: FDA 510(k) K151686
Whats in the Box ?
1. Ergo Pen II
2. Portable carry case which holds pen, three needles, two -3ml Vials
3. X four 3ML HTC Sterile Vials (57mmx130mm)
4. x three scew on sterile disposible needles (0.23x4mm)
📌 Device Classification & Regulatory Details
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Device name: Ergo Pen II
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Manufacturer: Eli Lilly and Company
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Regulatory class: Class II piston‑syringe device
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FDA clearance: 510(k) K151686 (cleared 30 Dec 2015)
⚙️ Mechanical & Functional Specifications
Dose Delivery
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Dose range: 1 to 60 units per injection
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Dose increments: 1‑unit steps (fully adjustable)
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Over‑dial protection: If you dial too high, you can dial back without wasting insulin
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Injection mechanism: Manual mechanical piston drive (no electronics)
Cartridge Compatibility
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Compatible cartridges:
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Humalog® 3 mL (100 IU/mL)
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Huminsulin® 3 mL (100 IU/mL)
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Other Lilly 3 mL cartridges depending on region
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Source: Official user manual
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Cartridge holder: Screw‑type attachment for secure seating
Needle Compatibility
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Uses single‑use, detachable pen needles (not included)
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Compatible with standard pen‑needle brands (e.g., BD Viva® per NHS device guide)
Pen Construction & Components
From the official manual diagram:
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Pen body
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Dose knob
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Injection button
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Cartridge holder
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Plunger
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Inner & outer needle caps
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Rubber cartridge cap seal
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Paper tab (needle)
Designed for ergonomic grip and repeatable mechanical dosing.
📏 Physical & Usability Features
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Reusable lifespan: Long‑term mechanical use (no electronics to expire)
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Colour variants: Multiple colours depending on region (functionally identical)
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Ergonomic design: Shaped for stable grip and low‑force dose dialing
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Reset mechanism: Automatic plunger reset when inserting a new cartridge
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Safety: No insulin exposure during cartridge change
🧪 Intended Use
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Self‑injection of insulin using Lilly 3 mL cartridges
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Suitable for adults and children with proper training
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Designed for home and clinical use