HEINE S-Frame and HEINE S-Guard
HEINE Optotechnik GmbH & Co. KG
Dornierstr. 6 · 82205 Gilching · Germany
E-Mail: info@heine.com · www.heine.com
MED 2106 2020-08-21
Introduction
Please read and follow these instructions for use and keep them for future reference.
Intended Use
The HEINE S-Frame and HEINE S-Guard are designed for use exclusively with HEINE instruments and light sources. It should only be operated by qualified medical personnel within a professional healthcare facility.
For U.S. only: Federal law restricts this device to sale by or on the order of a Physician or Practitioner!
Warnings and Safety Information
▲ CAUTION! Indicates potential hazardous situations. Ignoring the corresponding instructions may lead to dangerous situations of mild to moderate extent. (Background color yellow; foreground color black).
NOTE! This symbol indicates valuable advice in terms of set up, operation or maintenance, as applicable. Notes are important, but not related to hazardous situations.
Operation
Retaining Cord
This stabilises your HEINE S-Frame and prevents slipping. Push the ends of the cord firmly over the ends of the temples. Adjust the length of the cord to suit your needs.
Adjusting the Nose Bridge
[A] This can be bent into position to suit the anatomy of your nose. By bending the bridge supports you can vary the distance between the lenses and the eyes.
Changing the Nose Pad
The nose pad is attached to the S-Frame by a screw. To change the nose pad, unscrew the screw and remove the old nose pad.
Adjusting the Temples
[B] The temple ends can be bent into shape in any direction. Adjust them until they fit comfortably.
Replacing a Temple
To replace a temple, simply unscrew the hinge screw, insert the new temple and screw in the hinge screw.
Fitting Optional Corrective Lenses
Please consult an optician before having corrective lenses fitted. Please show the optician the attached “Instructions for specifying corrective lenses”.
[C] To fit the corrective lenses, insert one side of the snap-in frame (2) into the groove in the S-Frame. [D] Next, insert the other side of the snap-in frame in the second groove.
To remove the snap-in frame with corrective lenses, reverse the above procedure, avoiding damage to the lenses.
Changing Protective Lenses
Hold the S-Frame as in [E] and bend the lens in the direction shown and pull the lens with an audible click out of the frame. To replace, follow the procedure shown in [F] and [G] until the lens clicks into place.
If the standard protective lenses are too close to your cheekbones, you can either fit the small protective lenses or adjust the nose bridge (A).
Instructions for Specifying Corrective Lenses
When specifying and fitting corrective lenses, be sure to take into account the following:
- The magnifying optics should be attached to the frame to suit your usual working posture.
- Prismatic errors should be corrected.
- The corrective lenses are mounted at an angle to the optical axis.
Check the correction by means of an eye test with the magnifying optics and the corrective lenses fitted. The HEINE SIGMA 250 eyepieces include 2 diopter lenses. This enables normalsighted, emmetropic patients to view the retinal image without effort.
The total spherical correction is usually max. +/- 5 dpt. Ask your optician!
The corrective lenses should be placed as closely as possible to the eyepieces of the magnifying optics.
Description and Assembly
Compatible Instruments
a) As a frame with mounting bracket for HEINE Instruments:
- HEINE SIGMA 250 Binocular indirect ophthalmoscope
- HEINE HR Binocular loupes
- HEINE HRP Binocular loupes
b) As eye-protection (Frame without temples), when mounted on the HEINE Professional L Headband fitted with the HEINE mounting bracket for HEINE Instruments:
- HEINE MD 1000 Fiber Optic Headlight
- HEINE ML4 LED HeadLight
- HEINE HR, HRP Binocular loupes
Fitting the HEINE SIGMA 250 to the HEINE S-Frame
Please follow the instructions supplied with the HEINE SIGMA 250.
Fitting HEINE Binocular Loupes with HEINE i-View to the HEINE S-Frame
Screw the HEINE i-View with your HEINE Binocular loupe to the fixing plate (Fig. 2). Please follow the instructions for adjusting the HEINE Binocular loupes and HEINE LED LoupeLight according to the instructions supplied with these units.
Assembly of the S-Guard with other HEINE Instruments
Screw your HEINE S-Guard to:
- Professional L Headband as in Fig. 1.
- ML4 LED HeadLight as in Fig. 3.
- MD 1000 F.O. HeadLight as in Fig. 4.
Diagram Descriptions
- Fig. 1: A close-up of a medical device component, showing a circular dial or adjustment knob.
- Fig. 2: The HEINE S-Frame protective eyewear fitted with HEINE binocular loupes.
- Fig. 3: A detail view of a HEINE medical instrument's attachment point, showing how a frame or headband might connect.
- Fig. 4: Another detail view of a HEINE medical instrument's attachment point.
- Diagram A (Nose Bridge Adjustment): Shows the eyewear's nose bridge supports being bent to fit the wearer's nose shape. Arrows indicate bending.
- Diagram B (Temple Adjustment): Shows the ends of the eyewear's temples being bent to conform to the wearer's head shape. Arrows indicate bending.
- Diagram C & D (Corrective Lens Fitting): Illustrates inserting a corrective lens frame into the S-Frame. Step C shows one side of the frame being inserted into a groove, and Step D shows the other side being inserted.
- Diagram E, F, G (Protective Lens Change): Shows how to remove a protective lens by gently bending the frame (E), and how to insert a new lens by aligning and pressing until it clicks into place (F, G).
Hygienic Reprocessing
General: The plastic protective lenses have an anti-reflex coating. Clean them carefully to avoid mechanical or chemical damage.
Cleaning: Clean the S-Frame and S-Guard with the included microfiber cloth. In addition, HEINE recommends the use of HEINE Cleaning Spray C-000.32.542. If other agents are used, for example, 70 % isopropyl alcohol, the durability of the spectacle frame is limited to max. 500 cycles.
Warning: Immersion disinfection, machine cleaning/disinfection, ultrasound cleaning and sterilisation are not permitted.
Maintenance and Service
Maintenance
The device is maintenance free.
Service
The device has no components serviceable by the end-user.
General Notes
The warranty for the entire product is invalidated if non-genuine HEINE products or non-original parts are used and if repairs or modifications are made to the device by persons not authorized by HEINE. For more information, please visit www.heine.com.
The expected life cycle amounts with designated use and the observation of warning and safety information as well as the maintenance instructions up to 7 years. Beyond this period, the product may continue to be used if it is in a safe and good condition.
This product is a precise optical instrument. Please handle this product with care and store it in a clean place.
General Warnings
▲ Check the correct operation of the product at regular intervals. Do not use the equipment if it shows visible signs of damage.
To avoid possible damage to the eyes, avoid looking directly at the sun or a bright light!
HEINE declines responsibility for any assembly defects caused by the optician. To avoid possible damage to the frame, avoid frequent bending of the temples.
Disposal
The product must be recycled as separated electrical and electronic devices. Please observe the relevant state-specific disposal regulations.
The appendix contains following tables:
- Technical specification
- Explanation of the used symbols
Technical Specifications
| Specification | Details |
|---|---|
| Weight | 25 g |
| Protective lenses | Plastic, anti-reflex coated |
| Frame | Nickel-free |
Environmental Conditions
| Condition | Details |
|---|---|
| For operation | +10 °C to +35 °C 30 % to 75 % rel. humidity 700 hPa to 1060 hPa |
| For storage | +5 °C to +45 °C 45% to 80% rel. humidity 500 hPa to 1060 hPa |
| For transport | -20 °C to +50 °C 45% to 80% rel. humidity 500 hPa to 1060 hPa |
Explanation of Symbols
CE Mark: Indicates compliance with the European medical device directive 93/42/EEC.
REF: Catalogue or order number.
SN: Serial number.
Manufacturer: HEINE Optotechnik GmbH & Co. KG.
Date of manufacture: Provided on the product label.
WEEE Symbol: Product must be disposed of separately as electronic waste according to local provisions.
Temperature Limits (°C): Specifies temperature ranges for storage and transport.
Temperature Limits (°F): Specifies temperature ranges for storage and transport.
Humidity Limitation: Specifies humidity limits for storage and transport.
Follow Instructions for Use: Indicates that the user must follow the instructions provided.
Fragile: Handle with care to avoid breakage.
Keep Dry: Store in a dry environment.
UDI: Unique Device Identification.
