RADIOEAR DD45C Audiometric Headphone Cushion Instruction Manual

RADIOEAR DD45C Audiometric Headphone Cushion

Specifications

• Standards: IEC 60645-1:2017, ANSI S3.6-2018, ISO 389-1:2017 & ISO 389-4:1994
• Transducer Type: Dynamic moving coil, custom built for audiometry
• Sound Pressure Level: 106.7 dB SPL at 1 kHz, 1 mW
• Total Harmonic Distortion: < 1% @ 100 Hz, 1,000 Hz & 6,000 Hz
• Weight: Approx. 380g
• Cable Length: 0.38 m to 5 m, depending on variant
• Compliance: RoHS 2011/65/EU incl. 2015/863

Product Usage Instructions

Connection and Compatibility
Only connect the RADIOEAR DD45 HEADSET to IEC 60601-1 and IEC 60601-1-2 approved devices. Ensure the device is not defective before use.

Calibration
Prior to use, calibrate the headset to the audiometric equipment it will be used with. This step is crucial for accurate results.

Cleaning Instructions
To clean the headphones:

• Use a soft, damp cloth for general cleaning.
• Avoid using organic solvents and aromatic oils.
• If needed, clean the cushions with a lint-free cloth lightly dampened in a cleaning solution.
• Avoid getting moisture in the speaker.

FAQ

Q: What should I do if I encounter a serious incident while using the headset?
A: In case of a serious incident related to the device’s use, immediately report the incident to DGS Diagnostics A/S and the local national competent authority.

Instructions for Use

• The DD45 is a supra-aural headset that can be used for audiometry testing for patients in all ages. The device converts electrical signals from the audiometer into air transmitted acoustic signals and couple these signals to the ear of the patient. The device is intended to be used by an audiologist, hearing healthcare professional, or trained technician.
• Warning : Only connect to IEC 60601-1 and IEC 60601-1-2 approved devices. Do not use a defective device.
• Caution : Before use, make sure the headset is calibrated to the audiometric equipment it is to be used with.

Cleaning instruction

To clean the headphones, use a soft, damp cloth. The use of organic solvents and aromatic oils must be avoided. If necessary, clean the cushions with a lint-free cloth lightly dampened in cleaning solution.
Make sure not to get moisture in the speaker.

Specifications

• Standards: IEC 60645-1:2017, ANSI S3.6-2018, ISO 389- 1:2017 & ISO 389-4:1994
• Earphone receiver: Dynamic moving coil, custom-built for audiometry
• Nominal impedance: 10 Ω
• Frequency response: 100 Hz – 8.000 Hz
• Sensitivity: 106,7 dB SPL at 1 kHz, 1 mW
• Distortion: < 1% @ 100 Hz, 1.000 Hz & 6.000 Hz
• Max. continuous power: 1 W
• Headband tension: 4.5 N ± 0.5 N
• Weight: approx. 380g
• Cable length: 0.38 m to 5 m, depending on variant.
• variants of DD45: DD45C (Contra) and DD45S (Shielded)

Compliant to RoHS 2011/65/EU incl. 2015/863
See www.radioear.us for range of spare parts and accessories

In case of serious incidents about the use of the device, the incident must immediately be reported to DGS Diagnostics A/S and the local national competent authority.

Symbol

1. Manufactured by
2. Year and month of manufacturing
3. Catalogue number
4. Model number
5. Temperature limitation transport
6. Temperature limitation storage
7. Humidity limitation
8. Discard according to regulations
9. CE mark
10. Consult instruction for use
11. Medical Device
12. Lot number
13. Unique device identifier

Manufactured for RadioEar by DGS Diagnostic A/S, Audiometer Allé 1, 5500 Middelfart, Denmark. Distributed by RadioEar, Audiometer Allé 1, 5500 Middelfart, Denmark

References

• The gold standard for audiometric transducers - RadioEar
• The gold standard for audiometric transducers - RadioEar

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