Why Saccadio Suite?

The Saccadio Suite offers a complete comprehensive eye examination done via Telemedicine. It is based on international standards and enables an offsite Ophthalmologist or Optometrist to perform an examination in less than four minutes.

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For the professional

 

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State of the Art Service

No appointment bookings and waiting times – instant “drop-in” examinations and results.

Impressive modern state-of the-art equipment.

The “Teledoctor” shares the examination results with the patient in a private face-to-face computerized meeting.

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More Examinations in less

Time & Space

The complete floor space needed is only 11 square metres, equalling 120 square feet. Ophthalmologists are able to complete an examination in less than three minutes.

The Saccadio Suite eliminates the need for the physical presence of the doctor in the clinic, local hospital or other locations, when performing the tests. The certified operator can be a nurse/technical staff, fully trained by HEADS, for the purpose of operating the system professionally.

Doctor’s office

Doctors are from the same state/country as the patient and are the relationship link for the patient. Patients might even have a choice between several Ophthalmologists. The service can be made available 24/7, no shortage due to holidays, leave or temporary staff re-sizing.

What we provide

The system is supported on a 24/7 basis, thus allowing customers to examine patients whenever they want.

Staff training is also included. Normal staff are able to perform patient recordings after 3 days of training.

If customers want to integrate Saccadio data into their existing medical data system, EMR data integration is offered to the client.

Services & Updates

All servicing of the Saccadio Suite will be made by certified/authorised centres, dedicated to minimise downtime for the operator; this includes repairs, updates (all included in the service) and upgrades.
Our service desk is open 24/7 and will receive calls and e-mails, with the possibility to chat, e.g. via Skype. Recalls will be handled promptly and new replacements of faulty equipment will be done a week.

Standards and Qualifications

The Saccadio Suite (PLUS) adheres to:

ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes
Medical Device Directive 93/42/EEC, amended with 2007/47/EC
FDA QSR 21 CFR Part 820 Medical Devices – Quality System Regulation (US)
EN ISO 14971:2012 Application of risk management to medical devices
IEC 62304:2006/A1:2015 Medical device software — Software life cycle processes
EN 62304:2006/AC:2008 Medical device software — Software life cycle processes
ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements
EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements
EN 1041:2008/A1:2013 – Information supplied by the manufacturer of medical devices
IEC 62366-1:2015 Medical devices – Part 1: Application of usability engineering to medical devices
EN 62366:2008/A1:2015 Medical devices – Application of usability engineering to medical devices

ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice
ISO 15004-1-2009 Ophthalmic instruments. Fundamental requirements and test methods. General requirements applicable to all ophthalmic instruments
IEC 62471:2008 Photo-biological safety of lamps and lamp systems
HEADS assumes all responsibilities for the disposal of all parts of the equipment following the EU: RoHS2 Directive 2011/65/EU European Regulation on Hazardous Substances and the WEEE Directive 2012/19/EU Directive on waste electrical and electronic equipment (WEEE). European Regulation of waste electronic equipment.

Headquarter Trondheim:

Address:
Heads AS, Havnegt 9, 7010 Trondheim, Norway
Phone: +47 90 99 01 99
Postal address:
Postbox 1273 Torgard, 7462 Trondheim, Norway

Office Stockholm:

Address:
Gustavslundsvagen 143 16751 Bromma
Phone: +46 70 234 95 04

email us