Inventis PICCOLO User Manual
  1. Manuals
  2. Brands
  3. Inventis Manuals
  4. Measuring Instruments
  5. PICCOLO
  6. User manual

Inventis PICCOLO User Manual

Portable audiometer
Hide thumbs Also See for PICCOLO:
Table of Contents

Advertisement

Quick Links

P
ICCOLO
P
A
ORTABLE
UDIOMETER
U
M
SER
ANUAL

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the PICCOLO and is the answer not in the manual?

Questions and answers

Related Manuals for Inventis PICCOLO

Summary of Contents for Inventis PICCOLO

  • Page 1 ICCOLO ORTABLE UDIOMETER ANUAL...
  • Page 3 Internal inspections and repairs must only be performed by authorised personnel. Copyright: Inventis srl has the copyright on this manual. It may not be copied, reproduced or altered, in total or in any part, without the written specific authorization from Inventis srl.

  • Page 4: Table Of Contents

    Summary Foreword ....................v CHAPTER 1 Safety: warnings and information ........1 Operator manual ................1 Operator responsibilities ..............1 Intended use ..................2 Indication for use and end users ............2 Precautions ..................2 Disposal ....................4 Conformity ..................4 Symbols on labels ................

  • Page 5: Foreword

    Bear in mind also that Inventis has developed a complete line of audiology devices: in addition to audiometers, the company's product line includes a range of middle ear analyzers, REM and HIT hearing aid fitting devices, a wireless video otoscope and much more.

  • Page 7: Chapter 1 Safety: Warnings And Information

    Defective and malfunctioning parts must only be replaced with original spare parts supplied by Inventis srl. All repairs must be performed exclusively by Inventis or by personnel authorised by Inventis.

  • Page 8: Intended Use

    NTENDED USE Piccolo medical device is an audiometer. An audiometer is a device that helps the operator in defining the patient’s auditory sensitivity by generating and delivering to the patient sound stimuli of different types and intensities for diagnostic purposes.
  • Page 9 IEC 60601-1. For further information, see “APPENDIX A: Technical Specifications”. The Piccolo audiometer is a medical device. Any other external device to which it is connected (such as a computer or CD player) within the “patient area” (as defined in IEC 60601-1) must also...

  • Page 10: Disposal

    ONFORMITY The Piccolo audiometer is a class IIa medical device according to Annex IX of the Medical Device Directive (MDD) 93/42/EEC as amended by directive 2007/47/EC.

  • Page 11: Symbols On Labels

    In particular, the number comprises these segments: first 5 characters: Inventis product code characters 6 and 7: year of manufacture (e.g. “12” stands for 2012) characters 8… 13: incremental number...
  • Page 12 UDI code...

  • Page 13: Chapter 2 Introduction

    Basic, Plus and Speech. AIN FEATURES The Piccolo audiometer is a portable unit that can be controlled from a computer or iPad. If connected to a computer, it can be controlled from Maestro, the medical record manager software application developed by Inventis able to interface also with Noah database.
  • Page 14 • Patient response switch • • • Clip-on microphone for talk-over • Jack / jack cable (diam. 3.5 mm) • • • Inventis Maestro Software • • • USB cable • • • Medical grade power supply (6V) • •...

  • Page 15: Chapter 3 Installation

    All connection points for accessories are located on the rear panel, as also is the power switch. This section refers to the Piccolo Speech audiometer. The Piccolo Plus does not have a LINE IN connector for an external sound source (following reported as EXT1, EXT2). The Basic model also lacks a BC...
  • Page 16 IEC 60601-1. For further information see “Appendix A – Technical Specifications”. If the Piccolo audiometer is powered via a USB cable, maximum values (in AC and BC) are 10 dB lower than nominal values. The green LED near the symbol indicates that the audiometer is powered either from the mains power adapter or via the computer’s USB cable.

  • Page 17: Connection To Computer/Ipad

    Aero models permit to control the device via Bluetooth from an iPad using Inventis Maestro app. available free of charge from the Apple App Store: for further details about the use and the features of Maestro App, and for...

  • Page 19: Chapter 4 Maintenance

    CHAPTER 4 Maintenance Piccolo audiometer does not require any special periodic maintenance other than calibration, checks and normal cleaning, all of which are described in this chapter. The performance and safety of the instrument will be maintained if the recommendations for care and maintenance given in this chapter are observed.

  • Page 20: Maintenance Of Transducers

    It’s basic also check that the calibration interval has not elapsed: the expiry of the interval is indicated at the top left of Maestro software. Calibration must be entrusted to technicians approved by Inventis srl. The operation should be performed at least once every 12 months, and whenever a transducer is replaced.

  • Page 21: Cleaning

    All the parts being returned to the manufacturer for repair and service shall be sterilized or disinfected and put in a transparent bag hermetically closed. Should the instrument need to be sent to the Inventis service department or returned to the dealer, it is important that the original packing should be used,...

  • Page 23: Appendix A Technical Specifications

    APPENDIX A Technical specifications Classification Piccolo Basic Type 4 pure tone audiometer (IEC 60645-1 / ANSI S3.6) Piccolo Plus Type 3 pure tone audiometer (IEC 60645-1 / ANSI S3.6) Piccolo Speech Type 3B pure tone audiometer (IEC 60645-1 / ANSI S3.6)
  • Page 24 Total Harmonic AC: less than 2,5 % Distortion (THD) BC: less than 5,5 % Frequency of the modulating signal: 5 Hz Warble tone Modulation waveform: sine wave Modulation range: ±12% Band: ½ octave, i.e.: - lower cut-off frequency f = f / 1.1892 - upper cut-off frequency f = f ·...
  • Page 25 SPEECH AUDIOMETRY MAXIMUM INTENSITIES TDH39 ER-3 DD65 ER-5 DD45 IP30 (dB HL) (dB HL) (dB HL) (dB HL) (dB HL) (*) Levels refer to devices powered by electricity network. In case they are powered by USB, maximum levels decrease by 10 dB. EXTERNAL SIGNALS LEVEL INDICATOR (only for Speech model) Type of indicator...
  • Page 26 • Pure tone audiometry • • • Auto-threshold • Speech audiometry QuickSIN™ opt. • Hearing Aid Master (*) available when controlled from the computer. AUDIOMETER CONTROL Without AERO With AERO option option Through computer with Inventis Maestro • • software.
  • Page 27 • Through iPad with Maestro App COMUNICATION WITH THE AUDIOMETER Computer iPad control control • USB 1.1 • Bluetooth 4 MINIMUM REQUIREMENTS FOR THE CONTROL DEVICE Computer Operating system Microsoft Windows 7 or sup., 32 o 64 bit Processor Intel Core 2 Duo 1.6 GHz or sup. 1 GB (suggested 2 GB) Minimum resolution 1024 x 768...
  • Page 28 Power supply DC plug 2.5 mm 2 audio jack, 1/4” mono L and R headphones Audio jack, 1/4” mono Bone vibrator (not in Piccolo Basic) Audio jack, 1/4” mono Patient response trigger External microphone for talk-over Audio jack, 3.5 mm mono...
  • Page 29 1500 2000 26.0 43.6 3000 4000 32.0 43.8 39.5 6000 8000 24.0 45.6 43.5 (*) With MX41\AR or PN 51 cushions REFERENCE EQUIVALENT THRESHOLD LEVELS ER-3 TDH 39 DD45 DD65 ER-5 B71* IP30 ISO 389-1 ISO 389-1 Vendor ISO 389-2 ISO 389-3 Ref.
  • Page 30 Modulation GFSK Integral antenna gain 0.5 dBi FCC ID: QOQBLE11 transmission module with IC: 5123A-BGTBLE112 CE CERTIFICATE 93/42/EEC MDD classification Class IIa Classification rule (Annex IX, 93/42/EEC) TÜV SÜD Product Service GmbH Notified body Ridlerstrasse 65, D-80339 Műnchen Number of the notified body 0123...

  • Page 31: Appendix B Troubleshooting

    APPENDIX B Troubleshooting Problem Possible cause Solution Transducer not Connect the transducer to the connected to the correct output correct output No signal from a transducer Transducer Contact your dealer or service damaged provider Connect the patient response Wrong connection No signal from button to the correct socket patient response...
  • Page 32 Problem Possible cause Solution The audiometer does not feature the Substitute the audiometer Aero option Faulty Bluetooth Contact your dealer or service module of provider audiometer Expired calibration Perform audiometer calibration Wrong kind of Unlikely exam selected AC Modify the selection of current results transducer AC transducer, from Maestro...

  • Page 33: Appendix C Electromagnetic Compatibility

    APPENDIX C Electromagnetic compatibility Piccolo has been thoroughly tested and respects the limits for electro-medical devices specified by IEC 60601-1-2 standards. These limits ensure reasonable protection against hazardous interference in typical medical installations. The instrument generates, uses and radiates radio frequency energy. If not installed and used according to the instructions in this manual, it may interfere with other nearby devices.
  • Page 34 No further steps are required. Guidance and manufacturer’s declaration – electromagnetic emissions Piccolo is intended for use in the electromagnetic environment specified below. The customer or the user of Piccolo should assure that it is used in such an environment. Electromagnetic environment-...
  • Page 35 IEC 61000-3-3 Guidance and manufacturer’s declaration – electromagnetic immunity Piccolo is intended for use in the electromagnetic environment specified below. The customer or the user of Piccolo should assure that it is used in such an environment. Electromagnetic IEC 60601...
  • Page 36 Guidance and manufacturer’s declaration – electromagnetic immunity Piccolo is intended for use in the electromagnetic environment specified below. The customer or the user of Piccolo should assure that it is used in such an environment. Immunity Test IEC 60601 Compl.
  • Page 37 RF transmitters, an electromagnetic site survey should be considered. If measured field strength in the location in which Piccolo is used exceeds the applicable RF compliance level above, Piccolo should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating Piccolo.

Table of Contents