Product Certification and Documentation:

• Valid Product Certificate from SRA Region: Required

• SRA Country of Origin: Specify

• Valid EFDA Product Certificate: Required

• Priority: 2

Product Information:

1. GMDN/UMDN Code/Name: Specify

2. Clinical Purpose/Description:
   Used for measuring intraocular pressure.

3. Technical Specifications:

   • Type: Portable, non-contact or rebound tonometer

   • Pressure Measuring Range: 7-60 mmHg with 0.5 mmHg increments

   • Head Rest: Adjustable knob

   • Power Supply: Rechargeable built-in battery

   • Display: Digital screen

   • Accuracy: ±1 mmHg

   • Increment: 0.5 mmHg

System Configuration, Accessories, Consumables, and Other Components:

• If the tonometer uses the rebound principle, at least 100 probes must be supplied (either individually or collectively packaged).

• A case or holder for the probe must be provided.

• A bag or case for storing the tonometer must be included.

• 1 rechargeable battery with charger.

Operating Environment:

• Operating Temperature: +10°C to +32°C

• Relative Humidity: <85%

Utility Requirements:

• Powered by a built-in rechargeable battery.

Standards and Safety Requirements:

• Must comply with IEC 60601 (or equivalent) General Requirements for Electrical Safety.

• Valid Certification from SRA Region countries required.

Installation, Training, and Commissioning: Not Applicable (NA)

Warranty and After-Sales Service:

• The supplier must provide a minimum of two years' warranty from the date of delivery.

• The supplier must offer after-sales service for the duration of the warranty period.