Technical requirements for essential elements of customized disposable hysteroscope

Product Name: Disposable Hysteroscopy

Model: Customized according to customer needs

Developed by: Shenzhen Ojos Medical Co., Ltd

一、 Basic specification parameter requirements

Customized products must specify the following core dimensions and optical parameters, which must be clearly marked in the technical agreement:

Parameter type optional range/requirement description

Outer diameter (OD Tip) 3.5mm, 3.8mm, 4.8mm, 4.85mm, 5.0mm, 5.1mm, 5.2mm, 5.4mm can be selected according to the surgical channel and operational requirements

The ID Working Channel inner diameters of 1.4mm, 2.0mm, 2.2mm, 2.4mm, and 3.0mm determine the size of surgical instruments that can pass through

Working Length 200mm (standard) or customized to ensure smooth access to the surgical site

The larger the field of view (FOV) of 120 ° or 140 °, the wider the observation range

Depth of Field (DOF) of 5-50mm or 5-100mm determines the closest and farthest range for clear imaging

Remote viewing angle (Direction) 30 ° (standard) or customized for easy access to the uterine cavity and reduced blind spots

Material: Metal Tube ensures sufficient rigidity and durability

二、 Function and Operation Design

Adjustment function: A 360 ° rotary adjustment knob must be equipped for precise adjustment of the remote lens angle.

lighting:

LED models: Available in models such as 9653 (high brightness) or 0301.

Number of LEDs: 2 or 4, depending on the outer diameter and brightness requirements.

Brightness control: Supports dimming function (manual or automatic) to adapt to different organizational environments.

Imaging sensor:

Optional models: OV9734, OV9734FPC (140 ° FOV) or OVM6946 (120 ° FOV).

Requirement: Provide high-definition, low-noise image quality with realistic color reproduction.

Flushing system: It must be designed with independent inlet and outlet for flushing the uterine cavity and maintaining clear visibility

Clear.

三、 Connection and compatibility

Output interface:

Standard USB output, can directly connect to various display devices.

Optional professional interfaces such as Lemo (Gold Finger B) are available.

Compatible devices: The following device types must be compatible:

Smartphone (Phone)

LCD Screen

Laptop computer

Professional Image Processor

Plug and play: No need to install additional drivers or software (compatible with UVC protocol), images can be displayed after connection.

4、 Disposable and sterile assurance (customers need to disinfect themselves)

Aseptic packaging: Each product must be packaged using an independent sterile barrier system (such as Tyvek paper plastic bags).

Validity period: Clearly label the sterilization validity period of the product.

Non reusable design: The product design should ensure that it cannot be safely cleaned, sterilized, and reused to eliminate the risk of cross infection.

Label identification: The packaging must have clear and non removable Chinese and English labels, including:

Product name, model, and specifications

Production batch number, serial number

Sterilization date and expiration date

Manufacturer information

五、 Packaging and Delivery Requirements (Additional Customization Required)

Inner packaging: A single hysteroscope is individually sterile packaged.

Medium packaging: Several individual products are packaged in one box for easy access and management.

Outer packaging: corrugated cardboard box, ensuring that the product will not be damaged, compressed, dampened or contaminated during transportation.

Accompanying documents: Each box of products should provide a packaging list, product qualification certificate, and user manual (in both Chinese and English).

六、 Registration and Compliance Requirements

Quality System: Product production must comply with the ISO 13485 Medical Device Quality Management System standard.

Regulatory certification: The product must meet the regulatory requirements of the target market and provide corresponding certification or conformity declaration:

Chinese market: NMPA registration certificate (formerly CFDA)

European market: CE certification (compliant with MDR regulations)

US market: FDA 510 (k) clearance (if applicable)

Instruction manual: Provide detailed instructions in both Chinese and English, including product introduction, usage instructions, contraindications, precautions, and warnings.

Shenzhen Ouzhuosi Medical Co., Ltd

Shenzhen Ojos Medical Co., Ltd.

Address: Room 401-407, Building B, Haohezi Chuang, No. 10 Fuyuan 2nd Road, Zhancheng Community, Fuhai Street, Bao'an District, Shenzhen

Contact:   info@ojos-medical.coms