CE70 User Guide Ver 2.0 April 2011

Introduction The CE70 is a small hand held warbletone audiometer with six output levels and set centre frequencies that will fit into a coat pocket or briefcase. It has many areas of use as described later in the section entitled ‘Indications For Use’. The CE70 is a popular instrument for hearing screening and to date over 4000 units have been built and these are providing valuable service in many countries of the world.

Specification Test centre frequencies Maximum output at 50cm Attenuator range Output level calibration Modulation frequency Modulation level Stimulus rise and fall time Electrical distortion Acoustic distortion Battery Size (mm) Weight Accessories Case

500Hz, 1K, 2K, 3K, 4K and 6K 70dB HL at all frequencies 20-70dB in 5dB steps +/- 5dB 10Hz +/- 10% +/- 10% 100msecs. nominal Better than -35dB THD Better than 30dB PP3 Alkaline type 6LR6 140 x 60 x 30 250g None Leatherette wallet

In order to maintain performance, the CE70 must be calibrated once every 12 months. The expected service life of the equipment is defined by the manufacturer is 5 years. The CE70 is classified as Internally Powered Equipment (BS EN 60601-1:2006) Class 2A for the Medical Devices Directive.

Environment Operating temperature: Humidity: Atmospheric pressure:

+15 to +30C 10% to 90% non condensing 500Pa to 1060Pa

Storage temperature: Humidity: Atmospheric pressure:

-10C to +50C 10% to 90% non condensing 500Pa to 1060Pa

Description Of Controls 2 1

3 1. On/off switch 2. Battery LED Green = Battery level ok Red = Battery level low

4

3. Presents the stimulus set up on the control switch. 4. Controls the output level from 20dBHL to 70 dBHL in 5dB steps.

5

5. Sets the centre frequency of the test stimulus.

Before Use The CE70 is supplied with the battery not fitted. Check that you have the correct type of battery, a PP3 Alkaline battery. DO NOT use a rechargeable or any other type of battery other than the one recommended. To fit the battery, ensure any battery terminal covers are removed (if any) and slide the battery cover away from the main body of the case. Check that the battery is the correct way round (see diagram on label in compartment), and push firmly in. Slide the battery compartment lid back until it clicks back. Turn the CE70 on and check that the battery level LED shows green. If it does not, check the fault finding section.

Using The CE70 Although the CE70 is extremely easy to use, for the best results, it should be used by trained personnel. The test should be carried out in either an acoustically treated room or a room that has a fairly low ambient noise level. Testing in a noisy room can give unreliable results. Switch the CE70 on and check the battery LED shows green. If it shows red, replace the battery by following the instructions in the section entitled BEFORE USE. After selecting the required centre frequency and output level, position the CE70 to the side of the subject in line with the ear and approximately 50cm away. Small variations in distance of +/- 10cm will not have a significant effect on the result. For best results, the ear not being tested should be covered up or have an earplug fitted. Pressing the Stimulus button will present the warbletone. Ensure the patient cannot see the button being pressed as this will give visual clues.

If the subject does not respond to the sound, increase the level by 5dB and repeat the test. Continue this procedure until a response is obtained. Select the next frequency and repeat the sequence. Continue the test for all frequencies, either making a note of the level at each frequency or plotting the results directed on to an audiogram sheet. Should distraction techniques be required, the one handed operation of the CE70 will prove useful. If during a test the battery level LED changes from green to red, the test can be continued but the two top levels should not be used. Replace the battery as soon as possible. NOTE: If the CE70 is not going to be used for some time, the battery should be removed. Dispose of used batteries using an approved disposal system.

Areas Of Use The CE70 can be used in many areas of audiology. Paediatric screening for babies older than three months. Testing people wearing hearing aids. Screening in schools, health centres, GP surgeries, clinics and hospitals. Industrial screening General screening purposes For use by health visitors, nurses and paediatricians etc.

Cleaning The CE70 must not be subjected to normal sterilisation procedures. It can be wiped over using a slightly damp cloth, or an IPA (Isopropyl Alcohol) impregnated cloth wipe.

Fault Finding The CE70 does not contain any user serviceable parts, so apart from simple problems, the unit must be returned to the manufacturer or distributor for repair. LED shows red:

Replace battery

No output sound:

Move output level control through all positions and try again. Do the same for the frequency control. If the level is set to 20dB and the frequency to 6Khz, it can be difficult to hear if there is background noise.

For other faults:

Return to manufacturer or the distributor

Declaration The manufacturer or its authorised distributors will make available on request, circuit diagrams, parts lists, descriptions, calibration instructions or other information which will assist the user’s appropriately qualified technical personnel to repair those parts of the equipment which are designated by the manufacturer as repairable.

Manufacturers Declarations Guidance and manufacturer’s declaration - electromagnetic emissions. The CE70 is intended for use in the electromagnetic environment specified below. The customer or the user of the CE70 should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic guidance

RF emissions CISPR 11

Group 1

The CE70 uses RF energy only for its internal function. Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

The CE70 is suitable for use in all establishments included domestic establishments and those directly connected to the public low-voltage supply network that supplies buildings used for domestic purposes.

The CE70 is intended for use in the electromagnetic environment specified below. The customer or the user of the CE70 should assure that it is used in such an environment. Immunity test

IEC60601 test level

Compliance level

Electromagnetic environment guidance

Electrostatic discharge +/- 6 kV contact (ESD) IEC 61000-4-2 +/- 8 kV air

+/- 6 kV contact

Floors should be wood, concrete or ceramic tile. If floors are covered with a synthetic material, the relative humidity should be at least 30%.

Power frequency (50/60Hz) Magnetic field IEC 61000-4-5

3 A/m

3 A/m

+/- 8 kV air

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.