¶ Converter Box 900 — Instructions for Use (IFU)
Document ID: 1024704-CB900-IFU-EN • Version: 1.0 • Date: 2025-08
Applies to: 1024704 - Converter Box 900
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¶ Preface
Thank you for choosing a Haag-Streit by Nexio device. This product is manufactured by NEXIO Sàrl (legal manufacturer) and supplied as an OEM solution to Haag-Streit. Provided you comply carefully with the regulations in these instructions for use, we can guarantee reliable and trouble-free use of our product.
- Before using this machine, read this user manual carefully and completely. Understanding the information provided is essential for safe and effective operation. Failure to follow the instructions and safety notes may result in injury, damage to the machine, or void the warranty. Keep this manual accessible at all times for reference during operation and maintenance.
¶ 1. Safety
¶ 1.1 Residual risks
Even when used as intended, some residual risks remain. If the machine is not used according to the manufacturer’s specifications and intended use, hazards may arise. Always follow the guidance in this IFU and applicable local regulations.
- Do not modify the device without manufacturer authorization.
- Installation and servicing must be performed by trained personnel.
- Use indoors only; maintain adequate ventilation—do not block vents or place inside closed cabinets.
- Keep away from strong RF emitters and ESD sources; maintain cable strain relief.
- Ensure the USB-C power adapter rating matches the specification; use only certified PSUs.
- Place the unit so the power connector is easily accessible for disconnection.
- Read these instructions fully before use and retain for all operators.
- Use genuine or approved accessories and cables only.
- This device itself is not a medical device. It is designed to be connected to medical devices in order to convert, route, and exchange data (e.g., RS-232, JSON, API, NFC).
¶ 2. Intended use
The device is to be used exclusively for the purposes specified in this manual; in case of doubt, please contact NEXIO Sàrl, Haag‑Streit, or your local supplier for more information.
The Converter Box 900 is intended to enable data conversion and connectivity in ophthalmology.
It connects diagnostic devices to each other or to electronic medical record systems (EMR) by translating between different communication protocols.
¶ 2.1 Supported functions
- Convert RS-232 serial protocols into standardized formats (JSON to REST API or webhooks).
- Exchange data with Nexio NFC cards and EyeCard chip cards.
- Allow older or brand-specific instruments to be integrated into modern IT workflows.
- Transfer refraction and measurement values directly to EMR systems or other devices.
¶ 2.2 Typical applications
- Connection of autorefractors, phoropters, keratometers, lensmeters, tonometers, pachymeters and similar instruments.
- Direct link between autorefractors or lensmeters and a Haag-Streit Refractor 900.
- Automatic transfer of diagnostic results, reducing manual data entry.
- Multi-brand integration, where instruments from different manufacturers are unified through the box.
- See the Compatibility list for a complete and updated overview of supported devices.
¶ 2.3 Intended users
- Daily operation: ophthalmologists, optometrists, orthoptists, medical secretaries.
- Installation and configuration: Haag-Streit trained technicians or authorized distributors.
¶ 2.4 Limitations
- The Converter Box 900 is not a medical device.
- It must not be used for direct patient diagnosis, therapy, or life-support applications.
- This device must not be operated near high-frequency surgical equipment or inside the RF-shielded room of an MRI system, where electromagnetic disturbances are high, or with devices not validated by Nexio.
¶ 2.5 Regulatory qualification (software) — interoperability / format conversion / transport (non‑medical)
Intended purpose (software scope)
The Converter Box 900 with nexSoft is intended exclusively for interoperability, format conversion, and transport of data between ophthalmic instruments and IT systems (e.g., RS‑232 ⇄ JSON/API/webhooks/NFC). It does not perform clinical analysis, interpretation, triage, prioritization, or decision‑support, and it does not control the clinical functions of connected instruments. The medical measurements are generated by the connected instruments; the box/software merely relays and reformats them for compatibility.
Regulatory qualification (summary)
Based on this intended purpose, the software is not considered a medical device in the following principal frameworks, which recognize pure data transport/format conversion as non‑medical functionality:
- EU / EEA / Switzerland (MDR-aligned) — Refer to MDR Article 2 and MDCG 2019‑11 guidance on software qualification. Pure communication/formatting without providing information used for diagnosis/monitoring/treatment is not a medical device.
- United Kingdom (MHRA) — MHRA stand‑alone software flowchart and guidance reach the same conclusion for software whose purpose is limited to interoperability and format conversion.
- United States (FDA) — Such functionality generally falls under MDDS (Medical Device Data Systems) policy, i.e., transfer / storage / display / format conversion without altering the clinical meaning; the FDA applies enforcement discretion to MDDS.
- Australia (TGA) — Software that solely provides data transmission/formatting is typically treated as excluded software when no medical purpose is claimed.
- Singapore (HSA) — Under HSA SaMD/CDSS guidance (e.g., GN‑13), software limited to interoperability/format conversion and with no clinical purpose is not regulated as a medical device.
- Global alignment (IMDRF) — The above positions are consistent with IMDRF SaMD foundational documents, where intended medical purpose is the key determinant.
NOTE
The above statements are based on publicly available guidance documents (MDCG 2019‑11, MHRA guidance, FDA MDDS policy, TGA excluded software framework, HSA SaMD/GN‑13, and IMDRF SaMD documents). Local implementation and enforcement may evolve; distributors should verify country‑specific expectations where necessary.
Out‑of‑scope / limitations (compliance guardrails)
To maintain the non‑medical status described above, the following constraints apply:
- No clinical analysis, derivation/recalculation of measurements, decision‑support, or alerts intended for clinical action.
- No control of clinical operating parameters of connected instruments.
- No modification of the clinical meaning of the transmitted data; only mapping, routing, and format/units conversion (e.g., in→cm) without changing medical significance.
- Any future feature that introduces clinical calculation, interpretation, or device control may change classification and could require compliance as SaMD (e.g., MDR Rule 11 in the EU, or non‑MDDS software in the US).
¶ 3. Device overview
¶ 3.1 Composition
- Converter Box 900: Complete unit with integrated enclosure, status LEDs, and RS-232 connectivity.
¶ 3.2 Connectors
- ① Ethernet (RJ-45, 10/100/1000)
- ② USB-A (host)
- ③ USB-C (power input, min. 5 V / 3 A certified PSU required)
- ④ Reset button (technician-only; do not press unless instructed by service)
- ⑦ RS-232 (DB9 male, connect the RS-232 cable supplied with the medical device to be interfaced)
Note: ⑤ and ⑥ are the LED indicators (see §3.3).
¶ 3.3 Indicators (LEDs)
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⑤ Red LED (left):
- On → device is powered.
- Off → no power, check the USB-C 5 V supply.
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⑥ Green LED (right):
- Off → system not operational, contact your distributor.
- Blinking (heartbeat) → system is running normally.
¶ 3.4 What’s in the box
- Converter Box 900
- 4 × rubber feet (self-adhesive)
- 2 × labels with technician login credentials for WebUI access
- The power supply is not included.
- Use a certified 5 V / 3 A USB-C adapter provided by your distributor or local supplier.
- The Mean Well NGE100 series is recommended (used for CE electrical testing); use the 5 V output variant.
¶ 3.5 Accessories & optional components
- NFC Reader with licence (optional) PN: 1024705 – for reading/writing patient refraction data (requires activation license).
- NFC Transfer Card (5 pcs) (optional) PN: 1024706
- RS-232 cables recommended by the instrument manufacturer (as applicable).
¶ 4. Transport, storage, and ambient conditions
- Transport temperature: −20 °C … +70 °C
- Storage temperature: −10 °C … +55 °C
- Operating temperature: 10 °C … +35 °C
- Relative humidity: 30 % – 90 % (non-condensing)
- IP protection: IPX0 (indoor use, no protection against liquids)
- Maximum altitude: 2000 m above sea level (asl)
- Pollution degree: 2
- Overvoltage category (OVC): I
¶ 4.1 Transport instructions
- Ship in the original packaging or equivalent protective packaging.
- Avoid shocks, vibration, and moisture ingress; keep the product dry.
- Do not stack heavy items on top of the unit during transport.
- After unpacking, visually inspect for damage before commissioning.
- After transport/storage, allow the unit to acclimatize to room temperature to avoid condensation.
¶ 5. Installation / assembly
Installation and initial configuration of the Converter Box 900 must only be performed by a Haag-Streit trained service technician or an authorized distributor.
End-users are not permitted to open or modify the unit.
¶ 5.1 General installation guidelines (for reference)
- Place the unit on a stable, flat surface with free airflow on all sides.
- Connect the required interfaces (Ethernet, USB, RS-232) to your equipment.
- Connect the USB-C power supply but do not power on yet (if PSU has a switch).
- Ensure cables are routed safely and that the unit remains accessible for power disconnection.
- Use shielded RS-232 cables where possible and route signal cables away from power/RF sources.
- Fit ferrite cores on long cables if EMC issues are observed.
- ESD: before handling connectors, touch a grounded metal surface to dissipate static.
- When wall-mounting or installing in a rack/shelf, ensure ventilation clearances (≥ 20 mm each side) and that the ambient temperature remains within specifications.
¶ 6. Commissioning (power on/off)
Power on
- Connect the USB-C power adapter. The Converter Box 900 will boot automatically.
- No additional action is required for normal operation.
Power off
- Disconnect the USB-C power connector to remove power completely.
- Use only external power supplies compliant with IEC/EN 62368-1, rated ≥ 5 V / 3 A, certified CE/UL.
- The Mean Well NGE100 series is recommended (used for CE electrical testing); use the 5 V output variant.
- Always ensure that the power connector remains easily accessible for disconnection.
¶ 7. Operation
¶ 7.1 General operation
The Converter Box 900 operates as a transparent bridge/converter between ophthalmic equipment and IT systems. For the end-user, the process is fully automatic. All configuration and setup are handled by authorized technicians via WebUI or API, ensuring smooth integration without user intervention.
¶ 7.2 Supported data flows
The system enables several types of data communication:
- RS-232 → JSON REST API for seamless integration with EMR systems.
- RS-232 → Haag-Streit Refractor 900 providing direct connection of an autorefractor or lensmeter.
- Nexio NFC / EyeCard (optional, requires an external card reader and activation license) allowing reading and writing of patient refraction data.
- Webhooks for automated transfer of data to third-party applications.
¶ 7.3 End-user interaction
For most applications, the Converter Box 900 runs in the background without requiring user interaction. When the optional NFC/EyeCard accessory is in use, the only user action is to insert or remove the card to trigger reading or writing of data.
¶ 7.4 Good practice
To maintain reliable operation, the following practices are recommended:
- Use compliant RS-232 cables, preferably those recommended by the equipment manufacturer.
- Ensure that cables are firmly connected and inspected regularly for wear.
- Keep ventilation paths clear; do not block or stack equipment on the unit.
- Restart the unit periodically – a daily reboot is ideal, but at minimum once per week.
- If the system appears unresponsive or data transfer stops, perform a power-cycle reboot.
¶ 7.5 Typical workflows
A common scenario is the connection of a lensmeter or autorefractor directly to the Haag-Streit Refractor 900, enabling automatic transfer of measurement values for efficient refraction workflows.
Another example is the export of refraction data to an NFC/EyeCard, which provides a simple medium for wireless data transfer and patient portability.
¶ 7.6 Limitations
The Converter Box 900 is designed for use only with validated and compatible devices (see Compatibility List). It is not intended for direct diagnosis or patient connection.
¶ 8. Maintenance, cleaning and service
- Switch off the device and disconnect it from the power supply before performing any maintenance.
- Only authorized and trained personnel may perform maintenance and servicing.
- Always use original spare parts and accessories.
- Improper maintenance can lead to device malfunction and pose a danger to the patient and operator.
¶ 8.1 Device inspection
- Check the housing, connectors and cables regularly for visible damage.
- Ensure that all screws and fasteners are tight.
- Inspect the device for signs of wear or corrosion.
- Verify that the ventilation openings are not blocked.
- Ensure that all safety labels and markings are intact and legible.
- If any defects are detected, do not use the device and contact service.
¶ 8.2 Servicing
The device must be serviced at regular intervals by authorized service personnel.
Only original spare parts may be used for servicing and repair. The service interval depends on the frequency of use and the environment in which the device is operated.
¶ 8.3 Cleaning and disinfection
Clean the exterior surfaces of the device regularly to maintain hygiene and ensure safe operation.
Use a soft, lint-free cloth slightly moistened with a mild detergent solution. Do not allow any liquid to enter the interior of the device.
- Do not immerse the device or its components in liquids.
- Do not use aggressive cleaning agents, solvents or abrasive materials.
- Failure to follow the cleaning instructions may lead to electric shock or device damage.
After cleaning, disinfect external surfaces using wipes or solutions compatible with equipment enclosures (e.g., isopropyl alcohol ≤ 70%). Avoid chlorine-based, ketone, or abrasive products that may damage ABS. Follow the disinfectant manufacturer’s instructions.
- Ensure the device is completely dry before reconnecting it to the power supply.
- Only use disinfectants compatible with equipment enclosures (ABS); avoid strong solvents.
Do not autoclave or sterilize the device. Excessive heat or moisture can damage sensitive components.
¶ 9. Technical data
| Parameter | Value |
|---|---|
| Power input | 5 V DC via USB-C (±10%), recommended ≥ 5 V / 3 A certified PSU (not included) |
| Protection class | Class III, no protective earth (PE) |
| Interfaces | 1 × Ethernet RJ-45 (10/100/1000), 1 × USB-A (host), 1 × USB-C (power), 1 × RS-232 |
| Serial | RS-232 (DB9 male); use the device’s own RS-232 cable |
| Dimensions | 40 × 57.6 × 62.25 mm (H × W × D) |
| Weight | 100 g |
| Operating temperature | +10 … +35 °C |
| Storage temperature | −10 … +55 °C |
| Relative humidity | 30 % – 90 % (non-condensing) |
| Ingress protection | IPX0 (indoor use only) |
| Safety standard (design intent) | IEC/EN 62368-1 (A/V & ICT equipment) |
| EMC | Intended for Class B environments (residential/commercial) |
| Battery | No internal battery |
¶ 10. Regulatory information (CE / FCC / symbols)
For the software regulatory scope and qualification (non-medical, interoperability / format conversion / transport), see §2.5 Regulatory qualification (software).
¶ 10.1 CE
- This product is intended to be CE-marked for EMC and safety (information for non-medical ICT/A&V equipment).
- Harmonized standards (design intent): EN 62368-1 (Safety), EN 55032 Class B (emissions), EN 55035 (immunity) or successors.
- Protection class: Class III; ABS enclosure; device powered from external 5 V DC USB-C PSU.
- This product is RoHS compliant; REACH SVHC information available upon request.
- Translations available upon request.
¶ 10.2 FCC (USA)
FCC Statement (Part 15, Class B)
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
¶ 10.2.1 U.S. Responsible Party
Haag-Streit USA
3535 Kings Mill Road
Mason, OH 45040 USA
www.haag-streit-usa.com
¶ 10.3 Symbols used on product / documentation
|
CE – Conformité Européenne (EU conformity marking) |
|
FCC – United States Federal Communications Commission compliance marking (where applicable). |
|
WEEE – Do not dispose with household waste; separate collection required. |
|
DC – Direct current input. |
|
Refer to instruction manual/booklet – Read the instructions before use. |
¶ 10.4 Product label
¶ 11. Disposal (WEEE)
Electrical and electronic equipment must be collected separately from household waste.
Follow local regulations for WEEE disposal and recycling. Contact your distributor for take-back options.
¶ 12. Declaration of Conformity (DoC)
A Declaration of Conformity (CE) and a Supplier’s Declaration of Conformity (FCC SDoC) will be made available upon request from the manufacturer/distributor once conformity assessment is completed.
- CE tests completed include radiated emissions (EN 55032) and radiated immunity (EN 61000-4-3); see test reports.
- CE tests include electrostatic discharge immunity (EN 61000-4-2).
- FCC radiated emissions evaluated per 47 CFR §15.209.
¶ Manufacturer / Contact
NEXIO Sàrl
Route du Village 7
1587 Constantine
Switzerland
¶ Change history
- 1.0 (2025-08): Initial public release of IFU for Converter Box 900.