Guidance

5. Equipment

Updated 10 October 2024

Applies to England

The national programme within Public Health England (PHE) is responsible for agreeing the technical specification for screening equipment with NHS Supply Chain and defining the scientific evaluation required for equipment used within the national programme.

The NHS Supply Chain has secured a framework agreement that details equipment which has been assessed to make sure it complies with the technical specification and is fit for purpose and good value for money. However, equipment included in the framework:

• has not necessarily passed the further NHSP scientific evaluation
• is not necessarily screening equipment data quality (SEDQ) compliant

NHSP providers must only use equipment that is on this framework agreement and which has satisfied a detailed scientific evaluation as specified by the NHSP Programme and is SEDQ compliant.

The scientific evaluation will be undertaken under a contract arrangement between the equipment supplier and PHE.

The SEDQ compliance testing will be undertaken under a contract arrangement between the equipment supplier and Northgate Public Services (the supplier of the NHSP national IT system).

Testing costs will be met by the equipment supplier.

Suppliers of new screening equipment listed on the NHS Supply Chain framework agreement should contact the national programme for further information relating to the evaluation process and SEDQ compliance via the screening helpdesk.

Current equipment

The table below lists the equipment that is currently used in the English screening programme.

Manufacturer	Supplier	Model	Configuration	Intermediate software
Madsen	Belmont Medical Technologies LTD	Accuscreen Classic	TEOAE	Audble
Madsen	Belmont Medical Technologies LTD	Accuscreen Classic	TEOAE and AABR	Audble
Madsen	Natus Nicolet UK Ltd	Madsen Accuscreen V2	TEOAE	Acculink
Madsen	Natus Nicolet UK Ltd	Madsen Accuscreen V2	TEOAE and AABR	Acculink
Natus	Belmont Medical Technologies LTD	Algo 3i	AABR	Audble
Otodynamics	Otodynamics	Otoport OAE	TEOAE	Otolink
Otodynamics	Otodynamics	Otoport ABR	AABR	Otolink
Otodynamics	Otodynamics	Otoport OAE + ABR	TEOAE and AABR	Otolink

The table below gives an example of the approximate requirements of equipment by birth rate.

Screening equipment (test type)	AOAE (pieces of equipment per number of births)	AABR (pieces of equipment per number of births)	Combined AOAE and AABR (pieces of equipment per number of births)
Hospital site	1 per 1,000 births	1 per 1,800 births	1 per 1,000 births

Under the framework agreement, suppliers must provide services to support their equipment. These cover the following areas.

Intermediate software

The intermediate software enables secure upload of data from the screening equipment into the NHSP national IT system. This process is referred to as SEDQ.

The intermediate software that accompanies each piece of equipment is listed in the table above. This software also enables:

• screening equipment to be configured with the correct local services and facility names, usernames and passwords, test locations, test protocols, consent status and risk factors
• viewing of screening test data including waveforms (or a statistical graph)
• configuration of some aspects of the equipment or test settings (where applicable these settings are given in the sections below):

Software updates are released as required but usually no more than once a year. Providers are responsible for making sure they are using the most up-to-date versions of the equipment supplier’s intermediate software.

Consumables and parts

Bespoke consumables and parts, including cables, are purchased by local services through their normal procurement methods, for each type of equipment.

Calibration and maintenance

This should be carried out as per equipment specifications, through normal procurement methods. NHSP providers are responsible for ensuring their screening equipment is appropriately calibrated and maintained.

Repairs

The warranty period is specified by the supplier. Repairs outside of the warranty period should be carried out through normal procurement methods.

Training

Suppliers are responsible for providing training for their equipment which must adhere to national protocol. They provide user manuals, quality assurance (QA) check technical guides, quick-start guides and installation and user guides for their intermediate software. These are listed below for each equipment supplier.

Automated Auditory Brainstem Response (AABR) stimulus level

Each type of AABR screening equipment has undergone an independent measurement of the stimulus level that is actually delivered into the ear. This makes sure that all equipment delivers the same level irrespective of the nominal level shown on the equipment.

All AABRs must be performed using ear cups, earmuffs or earphones, not insert probes.

Accuscreen Classic (Accuscreen Pro)

Intermediate software: Audble

User guides

User guides are available from the equipment suppliers. Local screening services must make sure they have the most recent versions available of:

• Accuscreen Pro user guide
• Accuscreen Pro quick guide
• Audble installation guide
• Audble PHE user guide

Test settings

In the Accuscreen device, select menu, options, auditory brainstem response (ABR) configuration. Enter your password and set:

1. Notch filter setting: 50 Hz (Europe).
2. AABR stimulus level: 45dB.

The Accuscreen Pro user guide provides further detail. These settings must always be checked when equipment is returned from calibration or repair.

Upload instructions

The Audble PHE user guide provides instructions.

Supplier contact details

Belmont Medical Technologies LTD

Unit 6 Station Industrial Estate
Oxford Road
Wokingham
Berkshire
RG41 2YQ

Telephone 0870 600 9940

Madsen Accuscreen (Accuscreen v2)

Intermediate software: Acculink

User guides

User guides are available from the equipment suppliers. Screening local services must make sure they have the most recent versions available of:

• Accuscreen user ,manual
• Accuscreen AABR quick guide
• AABR screening with MADSEN Accuscreen v2
• Performing QA checks with MADSEN Accuscreen v2
• Acculink user manual

Further information is available on the Natus website.

Handset viewing screen order

To set the handset viewing screen order select the ‘System configuration’ tab and then complete the following instructions.

1. Select the field set up tab.
2. Set the following sorting order for the device patient list configuration:
   • first sort order – 1st field = Patient ID, 2nd field = a blank
   • second sort order – 1st field = Hospital ID, 2nd field = Patient Forename
   • third sort order – 1st field = Patient Surname, 2nd field = Patient ID
3. Save to confirm these settings.

Test settings

In Acculink, select the ‘Device Management’ tab, then:

1. Select the correct Accuscreen to edit from the list of devices.
2. In ‘configuration’ tab -> ‘common configuration’, set:
   • power time out: 10 minutes
   • calibration / pause: up to 30 minutes (option to be selected by local service)
   • test result terms: Clear response / No Clear Response
   • data deletion: after successful download
   • autostart AABR: no autostart option is recommended by NHSP - Autostart on green may be used
   • TEAOE probe fit assist: enabled
3. Save to confirm these settings.

In Acculink, select the ‘Device management’ tab then:

1. Select ABR configuration.
2. Set ABR configuration, ABR level to 45dB stimulus.
3. Save to confirm these settings.

The Acculink user manual provides further detail. These settings must always be checked when equipment is returned from calibration or repair.

Upload instructions

The AccuLink user manual provides instructions.

Supplier contact details

Natus Nicolet UK Ltd

Prospect House
Baynards Green Trading Estate
Bicester
Oxfordshire
OX27 7SG

Email [email protected]

Technical support 0870 900 0675

Natus Algo 3i

Intermediate software: Audble

User guides

User guides are available from the equipment suppliers. Local screening services must make sure they have the most recent versions available of:

• Algo 3i user manual
• Algo 3i quick guide
• Audble PHE user guide

Test settings

In the Algo 3i select ‘Main Menu’, ‘Device Setup’, ‘User Preferences’, then set:

1. Time/date format (mmm/dd/yy and 12-hour clock, with am and pm).
2. Speed Screen: disabled.
3. Alphanumeric data entry: enabled.
4. Input entry limit: allow input entry up to 24 characters.
5. The remaining options: default (default device location, default in patient facility, default outpatient facility, default NICU) for your site.

In the Algo 3i, select ‘Main Menu’, ‘Device Setup’, ‘Biomed Preferences’, then set:.

1. Notch filter setting: 50 Hz.
2. dBnHL parameters: omit 40dBnHL screening.
3. Password management: set new passwords or leave the default passwords.
4. Set Language: leave as English.
5. Set Required Fields: leave as set – Infant ID, Last Name and Date of Birth are required (this will disable the SpeedScreen facility, which is correct).
6. Set Export Options: not required.
7. Data Security Options: leave as set.
8. Validate the infant ID to be NHS format.
9. Save tests even if incomplete on both ears.
10. Restrict export and delete all records at once.
11. Default Configuration Profiles: always set this to Configuration Profile B.

The Algo 3i User Manual provides further detail. These settings must always be checked when equipment is returned from calibration or repair.

Upload instructions

The Audble PHE user guide provides instructions.

Supplier contact details

Belmont Medical Technologies LTD

Unit 6 Station Industrial Estate
Oxford Road
Wokingham
Berkshire
RG41 2YQ

Telephone 0870 600 9940

Otodynamics Otoport

Intermediate software: Otolink

User guides

User guides are available from the equipment suppliers. Local screening services must make sure they have the most recent versions available of:

• Otoport NHSP user manual
• ABR quick-start guide

Test settings

The equipment supplied by Otodynamics is preconfigured to meet the NHSP requirements. These settings must always be checked when equipment is returned from calibration or repair. No further configuration of test parameters is required. The AABR will show a setting of 40 dB to make sure conformity with other equipment used in NHSP. Please note that for this equipment AABR testing must be performed using headphones, not insert probes.

Upload instructions

The Otoport NHSP User Manual provides instructions.

Supplier contact details

Otodynamics Ltd

30-38 Beaconsfield Road
Hatfield
Herts
AL10 8BB

Email [email protected]

Technical support 01707 274700

Screening provider responsibilities

Screening providers are responsible for:

• maintaining sufficient equipment to screen their population and for repair or replacement of damaged equipment
• complying with local safety and acceptance testing and inclusion of equipment on the Trust asset register
• making sure that the most up-to-date versions of intermediate software and firmware are in use – providers should ask their local IT departments to install or update the intermediate software as required on every IT device that is used to upload screening data to the national IT system
• configurating the equipment in accordance with the NHSP requirements given in the current equipment, Accuscreen Classic, Madsen Accuscreen, Natus Algo and Otodynamics Otoport sections)
• making sure equipment is registered with the national IT system (this includes loaned equipment which must be de-registered when no longer in use)
• adhering to the manufacturers’ recommended methods for decontamination and making sure all cleaning regimes are approved by local infection control departments
• making sure that routine manufacturer and quality assurance checks are carried out to show that the equipment is functioning correctly (see screening provider responsibilities and maintaining a log sheet of this activity
• adhering to recommended maintenance and calibration schedules and maintaining a record of this activity
• managing faulty equipment and repairs
• disposing of equipment as per local policy, following discussion with the equipment supplier to make sure it is disposed of appropriately

Any concerns about recurring problems with equipment should be reported to the national programme via the screening helpdesk. This will help inform the national programme of issues to be raised with suppliers.

Equipment QA checks

There are a series of routine visual, probe and QA checks designed to identify faults or problems with the equipment. They must all be performed before the equipment is used to screen babies that day. If the equipment does not record the expected outcome for any of the checks, it must be removed from use until the fault is investigated and rectified.

Details about these checks are given in the manufacturer’s equipment manuals or technical guides. These describe the actions that can be taken when equipment does not record the expected outcome for one or more of these checks prior to contacting the suppliers.

The outcome of these checks should be recorded on an equipment log. Templates are available for these log sheets. These can also help services track any faults with their equipment. The QA check results are uploaded into the national IT system with the screening test results. Other routine checks are not uploaded but should be recorded on the log sheets to evidence manufacturer guidance has been followed, assuring local services equipment is working correctly and that no baby has been screened using faulty equipment.

There is a local programme management task to monitor adherence to the expected outcomes for QA and other checks to make sure that babies are only screened using equipment that have recorded appropriate checks before being used that day. The local manager is responsible for making sure that on at least a weekly basis all checks have been completed and uploaded for every piece of equipment used to screen any baby. Evidence of appropriate remedial actions should also be maintained locally.

In addition to any checks required by the equipment manufacturer, the following NHSP checks must be undertaken.

Visual checks (all equipment)

Visual checks should be carried out before the equipment is used to screen babies that day. Include a check of the overall condition of the equipment for cracks or damage and the sensor and probe or headphone cables for damage, weak or worn points especially where they attach to the equipment.

Probe test (Accuscreen AOAE and Otoport AOAE)

This checks that the loudspeaker is producing the correct stimulus level to evoke an OAE and that the microphone is measuring it. Details are given in the supplier’s manuals or technical guides.

QA1 cavity check (Accuscreen AOAE and Otoport AOAE)

This checks that when the AOAE probe is inserted into a test cavity there are no artefacts present that could be misinterpreted as a clear response. Details are given in the supplier’s manuals or technical guides.

Note that this test should never be carried out in a cavity other than the recommended test cavity. If a large cavity, such as the ear of a plastic doll, is used it is possible to obtain a false response. It is not good practice to use screening equipment that has an unexpected outcome for any QA check recorded on the day of use.

A clear response on the QA1 cavity check is the only unexpected QA check outcome that would require babies screened and discharged using that equipment to be recalled. This fault could suggest the equipment would fail to detect a deaf ear until it successfully records the expected ‘no clear response’ QA outcome when checked.

QA2 occlusion check (Accuscreen AOAE and Otoport AOAE)

This checks that the AOAE earpiece and cover are correctly assembled and that there is no leakage of signal between the loudspeaker and microphone. Details are given in the supplier’s manuals or technical guides.

QA3 real ear check (Accuscreen AOAE and Otoport AOAE)

This checks that the equipment is able to correctly detect a response from a hearing ear. In cases where the person carrying out the QA check does not normally get a clear response from their own ear and there is no one else available, the usual expected result is allowed. Details are given in the supplier’s manuals or technical guides.

QA4 AABR stimulus level and integrity of electrode leads (Algo 3i, Accuscreen and Otoport)

This checks that the AABR stimulus is being emitted via the loudspeakers for both ears and that the impedance levels for the electrode connections are appropriate when connected or disconnected. Details are given in the supplier’s manuals or technical guides.

Note that QA4 should be stopped once the stimulus has been heard and the connections checked. If the QA check is allowed to complete, there is a chance of an unexpected clear response.

For the Algo 3i, there is an additional, specific sequence of checks. Details are given in the Algo 3 user manual.

Screening equipment data quality (SEDQ)

SEDQ is an automated process that enables uploading of screening results from the screening equipment, via the intermediate software, into the national IT system – SEDQ reduces the risks associated with manual entry of patient test results, risk factors and demographic data. Further information about the SEDQ process is available within the national IT system resource tile user guides.

SEDQ provides a secure process because the screener must enter a login and password to access the equipment before screening. Screening test results are stored against the screener login at the location selected when uploaded to the national IT system.

It is possible to retrieve screening data from the national IT system to be viewed in the intermediate software. This may be required to view screening test conditions for an individual or group of babies or where a child is later identified with a permanent childhood hearing impairment (PCHI) and the audiology team would like to review the screening results.

Providers must check with equipment suppliers that they are using the most up-to-date version of the intermediate software. They should also be aware of:

• what to do if the national IT system is unavailable
• the procedure to follow if SEDQ data is missing from the national IT system
• how to retrieve screening data – guidance is available in the S4H advance user guide from the S4H resource tile

National programme responsibilities

The national programme is responsible for delivery of the essential elements of screening programmes which are best done once at national level. This includes:

• monitoring equipment performance and user intelligence to gather evidence that will inform improvements and future developments
• holding regular meetings with equipment suppliers, the NHS Supply Chain and disseminating updates as required
• investigating incidents involving equipment, including those where data did not appear in the national IT system (resolutions or lessons learned will be agreed with suppliers before dissemination)
• setting technical specifications for screening equipment for use by the NHS Supply Chain
• making sure equipment in use in the English screening programme has completed full scientific and compliance testing