Quality assurance and warranty

Quality assurance

Amplivox design, manufacture, supply products on a global basis to satisfy customer regulatory requirements. It is therefore essential that we have rigorous and proactive quality assurance schemes in place to ensure that we achieve our quality management goals at all times.


ISO 13485:2016

ISO 13485:2016 specifies the requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.


Three year warranty

Amplivox manufactured products include a three year warranty as standard.

We will correct, without any charge for parts or labour, all defects in the goods arising from faulty manufacture or failure of original materials or components, provided the goods are returned to Amplivox (carriage and insurance paid) before the expiry of the Standard Warranty period with a full account of the defects and such notification is determined to be correct.

Accessories, as outlined in Warranty Exclusions, are not included within the Amplivox warranty programme and plans. Should any items not covered by the warranty require repair or replacement, we will seek approval for the estimated costs for these items from you before commencing with any repairs.

Prices for these items are based on the repair time using only Amplivox approved parts. Calibration (on-site or return to base) is not included in the standard warranty.

 

What is excluded from the Amplivox standard warranty?

Routine maintenance and cleaning, unless specified in the extended warranty agreement. Carriage and insurance costs to the Amplivox service centre.

The cost of repairing or replacing consumable items or accessories intended to be replaceable. These include:

  Cables
•  Power supplies
•  Patient response buttons
•  Headsets
•  Headset Cushions
•  Printers and associated power and connecting cables
•  Labour and transportation costs if no fault is found with your equipment, and the issue is a result of user error

Labour charges for work outside the repairer’s normal working hours, Monday to Friday.

Repairs arising from theft, attempted theft, malicious damage or damage caused by fire, explosion or water / sprinkler damage. 

Costs or loss of revenue or income arising from not being able to use your equipment or from loss or damage caused when the equipment breaks down (consequential loss).

Cosmetic damage such as damage to paintwork or dents or scratches to the equipment, unless such damage is noted at the time of delivery to the site.

Repairs arising from your failure to follow the manufacturer’s instructions, and guidelines for use of the equipment. 

Repairs arising from abnormal conditions of working, accident, misuse or neglect or damage caused by fire or explosion.

Repairs arising from floods, lightning, storms, frost or other bad weather conditions. Repairs arising from any problem with the supply of electricity, gas or water.

Damage or failure of the equipment due to a software virus; the configuration of user settings; the installation of any non-Amplivox approved software; the process of backing up or recovery of data; loss, corruption or damage to data or operating systems.

Repairs for equipment not notified to Amplivox within 30 days of the issue first becoming apparent.

Repairs for an accessory used with the equipment not purchased from Amplivox as part of the original order for the equipment.

An Amplivox Warranty will not protect against claims arising from third parties or personal injury, however sustained.

 

The Amplivox standard and extended warranty is subject to the following conditions:


1. The instrument is forwarded carriage paid to Customer Service Department, Amplivox Limited, 3800 Parkside, Solihull Parkway Birmingham Business Park, Birmingham, West Midlands, B37 7YG, United Kingdom

2. That no attempt has been made to adjust the calibration (or interfere in any way with the instrument) by a third party other than an authorized employee of Amplivox Ltd or associated organisations.

NOTE: ALL INSTRUMENTS IN TRANSIT TO AND FROM AMPLIVOX LTD ARE AT OWNER’S RISK. THEREFORE, ANY INSURANCE AGAINST LOSS OR DAMAGE MUST BE EFFECTED BY THE OWNER.
 

Amplivox out of warranty services


For repairs or fault diagnosis on Amplivox equipment occurring outside of a Standard Warranty or Extended Warranty period, Amplivox offers a Return to Base repair service.

Once the instrument has been received by Amplivox, we will confirm your diagnosis of the fault and, if necessary, carry out further fault investigations. Once the fault has been correctly identified, we will seek approval from you for the estimated costs before commencing with any repairs. Prices for out of warranty repairs are based on the repair time using only Amplivox approved parts. Return carriage will also be charged.