Products

OEM Devices

 

Featured FDA Approved Device Designs for License or Purchase

You can endure all the risk, time, and pain of a scratch design, or you can start and finish with a proven solution from us. Available modules include electrocardiography and spirometry.

Electrocardiograph

Miniature, low power module allows the addition of up to 12 ECG channels to any medical system. This module is in production and being used in FDA-approved devices currently on the market. Available for purchase or license at any design level ranging from a complete source level design to manufactured subassemblies. Designed for systems required to meet the following standards:

  • ANSI/AAMI EC11 Diagnostic Electrocardiographic Devices

  • ANSI/AAMI EC13 Cardiac Monitors, Heart Rate Meters and Alarms

  • IEC 60601-2-25 Requirements for the Safety of Electrocardiographs

  • IEC 60601-2-27 Rqmnts. for the Safety of ECG Monitoring Equipment

Features:

  • Typical 12-lead channels: Leads I, II, III, aVR, aVL, and V1 to V6.

  • Integrated Muscle Artifact Filter

  • Isolated Serial Interface

  • Integrated Patient Isolation to Type CF Applied Part

  • Defibrillation Protection

  • Integrated Respiration Waveform Output

  • Respiration Rate Measurement 2-150 breaths per min

  • Pulse Rate Detection 30 to 300 beats per min

  • Pacemaker Pulse Detection

  • Leads-Off Determination

  • R-Wave Pulse Trigger Output

Manufactured Module:

  • Size: 3.2" (81 mm) x 2.8" (72 mm)

  • Nominal Supply Voltage: 5V

  • Nominal Supply Current: 40 mA

  • Nominal Power: 200 mW

Spirometer

Miniature, low power module allows the addition of diagnostic spirometry to any medical system. This module is in production and being used in FDA-approved devices currently on the market. Available for purchase or license at any design level ranging from a complete source level design to manufactured subassemblies. Designed for systems required to meet the following standards:

  • American Thoracic Society (ATS/ERS) 2005 Standard

  • British Thoracic Society (BTS) Standard

  • National Institute for Health and Clinical Excellence (NICE) Guidelines

Measured Parameters:

  • FVC, FEV0.5, FEV1, FEV6, FEV3, FEV1/FEV6, FEV1/FVC, FEV3/FVC, PEFR, PEFT, FEF25%, FEF50%, FEF75%, FEF25-75%, FEVC, FEV0.5, FIV1, FIV3, FIV1/FIVC, FEV3/FIVC, PIFR, FIF50%, FIF25-75%, FIF.2-1.2, FVC/FIVC, Extrapolated Volume, EOTV, FET, MVV, RR, MTV, SVC.

Range:

  • Flow: +/-14 liters/second

  • Volume: 0.5-8.0 liters

Flow:

  • FEF 25-75: 5% of indication or +/-200 ml/sec, (greater).

  • PEF: 10% of indication or +/-300 ml/sec, (greater).

Volume:

  • FVC and FEV1: +/-3% of indication or +/-50 ml, (greater).

  • MVV: +/-10% of indication or +/-15 L/min, (greater).

Precision:

  • Flow: PEF: +/-5% of indication or 150 ml/sec (greater).

  • Volume: FVC and FEV1: +/-3% of indication or 50 ml (greater).

Mouthpiece

  • Used with proprietary single-use pneumotachometers (mouthpieces).

Manufactured Module:

  • Size: 1" (25 mm) x 2" (51 mm)

  • Nominal Supply Voltage: 5V

Battery Powered Surgical Headlamp

 

Advanced Medical Electronics designed a high-efficiency power supply and performed thermal packaging analysis in support of the design of the original Halo surgical headlamp. The system is sold by Enova Medical Technologies of St. Paul, MN.

Wrist-Worn Pulse Oximeter

 

Advanced Medical Electronics teamed in support of the design of a wristworn Bluetooth oximeter intended for applications including cardio-ambulatory monitoring, remote wireless monitoring and overnight studies. The system is sold by Nonin Medical of Plymouth, MN.

Amplitude-Integrated Electroencephalograph

 

Advanced Medical Electronics designed the analog electronics and signal processing software for the CFM6000 neonatal cerebral function monitor. This system was sold by Olympic Medical of Seattle, WA which was acquired by Natus Medical Corp. of Pleasanton, CA.

Partial Polysomnograph

 

Advanced Medical Electronics designed analog electronics, embedded firmware, and software for a partial polysomnograph and other sleep disorders diagnostic instruments. These systems are sold by Nihon-Kohden a Japanese company, Grass-Telefactor (parent Astromed) of West Warwick, RI, which was acquired by Natus Medical Corp. of Pleasanton, CA, Viasys Healthcare of Conshohocken, PA, Pro-Tech Services of Mukilteo, WA, Respironics of Murrysville, PA, and Phillips Electronics of the Netherlands.

Computerized Visual Acuity Testing

 

Advanced Medical Electronics teamed in support of the design of CustomLinkTM for the Smart System® Tablet. CustomLink allows eye care professionals with sub-specialties to easily share the same exam room without compromising efficiency or throughput. CustomLinkTM is a new feature of the Smart System® Standard, from M&S Technologies of Chicago, IL, the most feature rich and flexible computerized visual acuity testing system available.