CE Marked medical device accessory in accordance with EU Regulation (EU) 2017/745 on medical devices (EU MDR), Class I (accessory for eye, ear, nose & throat devices)
Included in Hillrom / Welch Allyn EU Declaration of Conformity as product code 118 EC PanOptic Basic & Plus Eye Cup (set of 5)
Conforms to applicable EU directives and regulations cited by the manufacturer, including RoHS Directive 2011/65/EU for restriction of hazardous substances in electrical and electronic equipment (where applicable within the system context)
CE Marked medical device accessory in accordance with EU Regulation (EU) 2017/745 on medical devices (EU MDR), Class I (accessory for eye, ear, nose & throat devices)
Included in Hillrom / Welch Allyn EU Declaration of Conformity as product code 118 EC PanOptic Basic & Plus Eye Cup (set of 5)
Conforms to applicable EU directives and regulations cited by the manufacturer, including RoHS Directive 2011/65/EU for restriction of hazardous substances in electrical and electronic equipment (where applicable within the system context)
Not made with natural rubber latex as stated in manufacturer catalog documentation
Description
The Welch Allyn 118-EC PanOptic Basic & Plus Eye Cup is a reusable patient eyecup accessory, supplied as a set of five, designed for use with Welch Allyn PanOptic Basic and PanOptic Plus ophthalmoscopes. The eyecup helps establish and maintain the proper working distance from the patient’s eye, stabilizes the instrument against the brow, serves as a pivot point when panning around the retina, and screens out ambient light to support a clearer retinal view. It is supplied as an OEM accessory from Welch Allyn / Hillrom and is not made with natural rubber latex.
Bnefits
Establishes and maintains proper viewing distance between the ophthalmoscope and the patient’s eye
Stabilizes the ophthalmoscope head against the patient’s brow for more controlled examinations
Serves as a pivot point when panning around the retina to improve ease of use and field of view
Helps occlude ambient light, improving contrast during retinal examination
Reusable and easy to clean between patients
Supplied as a genuine OEM accessory specifically designed for PanOptic Basic and PanOptic Plus ophthalmoscopes
Not made with natural rubber latex, reducing risk for latex-sensitive patients and staff
Indications
Accessory for use during fundoscopic/ophthalmoscopic examination with Welch Allyn PanOptic Basic and PanOptic Plus ophthalmoscopes
Assists clinicians in maintaining appropriate working distance and alignment for adult and pediatric eye examinations
Helps improve image quality and patient comfort during routine eye exams and retinal assessments
Composition
Reusable medical device accessory (patient eye cup)
Not made with natural rubber latex (exact polymer composition not specified by manufacturer)
Class I medical device accessory under EU MDR for eye, ear, nose & throat (accessory to PanOptic ophthalmoscopes)
Not made with natural rubber latex as stated in manufacturer catalog documentation
PanOptic ophthalmoscope patient eye cups
Formulation
Reusable patient eye cup accessory compatible with Welch Allyn PanOptic Basic and PanOptic Plus ophthalmoscopes
Designed as a shaped eyecup that fits on the ophthalmoscope head to interface with the patient’s brow/orbital area
Packaging
Set of 5 reusable patient eye cups per pack
Supplied as OEM Welch Allyn / Hillrom accessory (118-EC PanOptic Basic & Plus Eye Cup, set of 5)
Usage
Attach the 118-EC eye cup securely to the compatible Welch Allyn PanOptic Basic or PanOptic Plus ophthalmoscope head according to the device instructions for use.
Position the ophthalmoscope so that the eyecup rests gently against the patient’s brow/orbital area, helping to stabilize the instrument and set the proper working distance.
Align the ophthalmoscope with the patient’s eye and perform the retinal examination, using the eyecup as a pivot point while panning across the retina.
Ensure that ambient light is minimized by correctly seating the eyecup against the brow, improving contrast and view.
After use, clean and disinfect the reusable eye cup according to the manufacturer’s cleaning and disinfection guidelines and local infection-control policies before using on another patient.
Inspect the eye cups regularly for wear, damage, or deformation and replace the set if integrity is compromised.
Contraindications
No specific contraindications are listed by the manufacturer for the 118-EC eye cup.
Use with caution in patients with known hypersensitivity or intolerance to any material in contact with the skin or periocular area, even though the device is not made with natural rubber latex.
Do not use a damaged, deformed, or visibly contaminated eye cup; replace the accessory if integrity is compromised.
Adverse Effects
No specific adverse effects are described by the manufacturer.
Potential for transient patient discomfort or pressure at the brow/orbital area if excessive force is applied.
As with any reusable accessory, inadequate cleaning and disinfection between patients may increase the risk of cross-contamination or infection.
Storage Conditions
Store in a clean, dry environment when not in use.
Protect from excessive heat, cold, and direct sunlight.
Follow general storage, handling, and cleaning guidance in the PanOptic ophthalmoscope instructions for use and any local infection-control policies.
Duration
Not applicable \u2013 used only during the duration of the ophthalmic examination as a diagnostic accessory.
Onset
Immediate during use \u2013 assists viewing and stabilization as soon as it is correctly positioned on the ophthalmoscope and patient.
