CE Marked medical device for tympanometric assessment in the EU/UK market.
Manufactured under an ISO 13485 Compliant quality management system for medical devices.
Designed and tested to applicable electrical safety and electromagnetic compatibility standards for diagnostic equipment (e.g. IEC 60601 series, as specified in the official documentation).
CE Marked medical device for tympanometric assessment in the EU/UK market.
Manufactured under an ISO 13485 Compliant quality management system for medical devices.
Designed and tested to applicable electrical safety and electromagnetic compatibility standards for diagnostic equipment (e.g. IEC 60601 series, as specified in the official documentation).
Meets relevant safety and performance requirements for tympanometric systems used in clinical environments.
Portable tympanometer / tympanometric instrument
Description
The Welch Allyn MicroTymp3 Portable Tympanometric Instrument is a handheld, battery-powered tympanometer designed to provide fast, objective assessment of middle ear status in patients of all ages, including infants less than six months old. It offers standard 226 Hz tympanometry plus a 1000 Hz quick-interpretation mode for infant screening, generating tympanograms in seconds to aid in the diagnosis of otitis media, middle ear effusion and eustachian tube dysfunction. The MicroTymp3 combines a lightweight handle with an angled probe, disposable ear tips, and a compact printer/charger base that recharges the lithium-ion battery and prints stored 226 Hz test results. Enhanced, field-upgradeable software, on-handle LCD display and memory functions support efficient workflow in clinics, ENT practices, paediatric settings and primary care. The MicroTymp3 is the direct replacement for the earlier MicroTymp2 model and is supplied as a portable set with charging stand and printer under SKU 93654.
Bnefits
Portable, handheld tympanometer that can be used at the point of care, at the bedside or in community settings.
Provides fast, objective measurements of middle ear status to support diagnosis of otitis media and related conditions.
Features a 1000 Hz quick-interpretation mode specifically for testing infants under six months, with on-screen messages to simplify interpretation.
Standard 226 Hz tympanometry with printed tympanograms via the dedicated printer/charger base for documentation and records.
Speed and ease of use make testing practical for young, restless or uncooperative patients; tests can often be completed in seconds.
Rechargeable lithium-ion handle with dockable printer/charger helps reduce downtime and maintains readiness for frequent use.
Field-upgradeable software and on-handle LCD interface support future enhancements and clear display of test parameters and results.
Welch Allyn build quality, serviceability and accessory ecosystem (tips, batteries, documentation cards, paper) provide long-term support.
Angled probe head and familiar otoscope-like ergonomics help clinicians achieve an effective ear canal seal quickly.
Meets relevant safety and performance requirements for tympanometric systems used in clinical environments.
Objective assessment of middle ear status in patients of all ages, including infants, children and adults.
Assisting in the diagnosis and monitoring of otitis media with effusion and acute otitis media.
Screening for middle ear effusion and eustachian tube dysfunction in primary care, paediatrics and ENT clinics.
Follow-up evaluation of middle ear conditions after medical or surgical treatment (e.g. grommet insertion) in line with local protocols.
Hearing and ear health screening programmes where rapid, portable tympanometry is required.
Composition
Handheld tympanometer handle with integrated probe and LCD display.
Lithium-ion rechargeable battery (REF 72910) installed in the handle.
Printer/charger base (REF 71170) for charging the handle and printing 226 Hz test results.
Disposable probe tips in multiple sizes (MicroTymp3 tips: extra small, small, medium, large, extra large; REF series 24620–24625).
MicroTymp3 1000 Hz documentation cards (REF 55270) and card holder (REF 55260) for recording infant screening results.
Thermal printer paper rolls for the printer/charger (e.g. REF 56100).
Power supply/cord appropriate to region and user manual / directions for use.
Formulation
Diagnostic medical device providing tympanometric measurements at 226 Hz and 1000 Hz probe frequencies.
Battery-powered, microprocessor-controlled tympanometer with on-handle controls, dual-frequency selection and memory for storing tests.
Operates with single-use ear tips to create an acoustic seal in the external ear canal.
Printer/charger provides AC-powered battery charging and thermal printouts of 226 Hz tympanograms; 1000 Hz infant mode provides quick-interpretation messages rather than printed traces.
Intended for use by trained healthcare professionals for diagnostic and screening tympanometry.
Packaging
MicroTymp3 set (SKU 93654) typically includes: MicroTymp3 handle with installed rechargeable battery, printer/charger base, power cord, starter assortment of probe tips, infant 1000 Hz documentation cards with holder, thermal paper and user documentation.
Components are packed in a protective presentation or shipping carton with internal inserts to secure the handle, base and accessories.
Outer packaging is labelled with product name (MicroTymp3 Portable Tympanometric Instrument), brand (Welch Allyn), SKU (93654), serial/lot information, regulatory markings and basic specifications.
Accessories such as replacement tips, batteries, documentation cards and paper are supplied separately under dedicated accessory SKUs.
Usage
Charge the MicroTymp3 handle by placing it in the printer/charger base for the recommended time before first use and as needed thereafter.
Install a fully charged lithium-ion battery in the handle according to the user manual, ensuring correct polarity and secure placement of the battery cover.
Select an appropriate size disposable probe tip and push it firmly onto the probe until fully seated.
Switch on the handle by pressing any button; the display will show the current test frequency (e.g. OPEN 226 or OPEN 1000).
To change probe frequency between 226 Hz and 1000 Hz, use the memory buttons as described in the directions for use, then confirm the desired frequency.
Gently pull the patient’s pinna to straighten the ear canal, position the probe tip at the canal entrance and press firmly to obtain an airtight seal.
Once a seal is achieved, the instrument will automatically run the test and display a tympanogram (226 Hz) or a quick-interpretation message (1000 Hz) when complete.
For 226 Hz tests, store results in the handle’s memory using the appropriate ear memory button and, if required, place the handle in the printer/charger and print the stored test.
For 1000 Hz infant mode, record the quick-interpretation message and value on the MicroTymp3 screening results card or into the patient record.
Remove and dispose of the used probe tip after each patient in accordance with infection control policies, and clean the probe and handle surfaces as per the manufacturer’s instructions.
Follow all warnings, contraindications and detailed instructions contained in the official directions for use and local clinical protocols.
Contraindications
Do not use in patients with known or suspected perforated tympanic membrane, recent ear surgery, or where tympanometry is contraindicated according to clinical judgement.
Avoid use in ear canals with significant obstruction by cerumen, foreign bodies, blood, discharge or other debris until appropriately managed.
Do not use if the device, probe tip or ear canal is visibly contaminated and appropriate cleaning or infection control measures cannot be ensured.
Use with caution in patients who are unable to cooperate or remain still; secure assistance as needed to avoid injury.
Do not use the instrument in the presence of flammable anaesthetics or in environments where the use of non-spark-safe electronic devices is restricted.
Adverse Effects
Mild, transient discomfort or pressure sensation in the ear during testing.
Occasional brief dizziness or imbalance sensation in sensitive individuals.
Rare risk of local irritation of the external ear canal, particularly if probe tip size or positioning is inappropriate.
Very rare risk of worsening pre-existing ear conditions if used contrary to contraindications or instructions for use.
Storage Conditions
Store the handle and printer/charger base in a clean, dry environment at normal room temperature.
Avoid exposure to excessive heat, cold, moisture or direct sunlight.
When not in use, place the handle in the printer/charger or designated holder to protect the probe and maintain battery charge.
Store disposable probe tips in their original packaging to protect from dust and contamination.
Do not immerse the device in liquids; clean only with approved disinfectant wipes or solutions as specified by the manufacturer.
Observe the battery manufacturer’s guidance for battery storage and replacement intervals.
