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Explanation of Symbols

This section explains all symbols used within this manual and on the device label.

Symbols within this manual:

Symbol

Explanation

Important notice: please read for important information.

Warning: please read for safety-relevant information, which may cause risk of
danger to persons and/or device if not followed.

Symbols on the device label:

Symbol

Explanation

Consult instruction for use, i.e. this manual.

Serial number

Article number

Medical device

Manufacturer name and address, production date

Compliance with applied part type BF (body floating) requirements
according to DIN EN 60601-1

Device with safety class II according to DIN EN 60601-1

Direct current input

The device is electronic equipment covered by the directive 2012/19/EC on waste
electrical and electronic equipment (WEEE). When discarded, the item must be
sent to separate collection facilities for recovery and recycling.

CE mark to declare conformity with medical device directive 93/42/EEC. The
number below the CE mark refers to the identifier of the notified body.

For further symbols, e.g. on accessory labels, please refer to the respective manual or data sheet of
the accessory. Important symbols may include:

Symbol

Explanation

Single use only. Do not reuse the respective item.

Expiration date. Do not use the respective item after the specified date.

Содержание Algo 7i

Страница 1: ...User Manual ...

Страница 2: ...Page 2 40 ...

Страница 3: ... mentioned items products brands and trademarks are registered or owned by the mentioned companies AABR ALGO Flexicoupler Jelly Tab and Natus are registered trademarks of Natus Medical Incorporated PATH MEDICAL GmbH Landsberger Straße 65 82110 Germering Germany Email info pathme de Telephone 49 89 800 765 02 Fax 49 89 800 765 03 All information illustrations and specifications provided within this...

Страница 4: ...tus Icons 12 3 4 Device Hardware 12 3 4 1 On Off Switch 12 3 4 2 Device Reset 13 3 4 3 Device Cable Connectors 13 3 4 4 Charging the Device 14 3 5 Device Functions 14 3 5 1 User Management 14 3 5 2 Patient Management 15 3 5 3 Device Settings 18 3 5 4 Hardware Tests 19 3 5 5 System Information 20 3 5 6 Test Module Information 20 3 5 7 Performing Measurements 20 3 5 8 Troubleshooting 23 3 6 ALGOLink...

Страница 5: ...e 31 8 2 Handling Transport and Storage 31 8 3 Electrical Safety 32 8 4 Electromagnetic Compatibility 33 8 5 Accessories 33 8 6 Waste Disposal 34 9 Technical Specifications 35 9 1 General Device Information 35 9 2 Device Characteristics 35 9 3 Power Supply 35 10 Electromagnetic Compatibility Information 38 ...

Страница 6: ......

Страница 7: ...e the hearing status of a newborn infant from 34 weeks gestational age to 6 months old Babies should be well enough for hospital discharge and should be asleep or in a quiet state at the time of screening The test methodology contains stimulus delivery EEG processing ambient noise processing PASS REFER determination screening conditions assessment ability to screen ears individually simultaneously...

Страница 8: ...ts on CNS central nervous system stimulants Infants receiving ototoxic medications Infants with compromised skin or jaundice Such infants may be screened once they are 34 weeks gestational age and healthy enough for discharge from the hospital but standard of care protocols should be followed as some of these conditions may be associated with delayed onset hearing loss Infants exhibiting cranio fa...

Страница 9: ...screening and 2000 sweeps for 40dBnHL screening The ALGO screener will continue to collect data up to 15 000 noise weighted sweeps If it has not established with 99 statistical confidence that the ABR signal is present after 15 000 noise weighted sweeps it will issue a REFER result The ALGO 7i hearing screener uses patented signal processing technology to separate the ABR from background noise and...

Страница 10: ...ating requirements according to DIN EN 60601 1 Device with safety class II according to DIN EN 60601 1 Direct current input The device is electronic equipment covered by the directive 2012 19 EC on waste electrical and electronic equipment WEEE When discarded the item must be sent to separate collection facilities for recovery and recycling CE mark to declare conformity with medical device directi...

Страница 11: ... Layout The device screen is divided into three main sections see Figure 1 Figure 1 Device screen layout Header including the following elements Device time e g 12 00 Screen related information e g Tab you are currently viewing USB connection is shown if USB cable is connected to a PC charging status indicator from empty to full Battery status Main screen including screen related elements e g Spee...

Страница 12: ...s correspond to the following definitions Test result PASS Screening passed successfully no further testing necessary Test result incomplete Screening should be repeated e g when baby is sleeping or in a calm state Test result REFER Screening referred Please consult your local facility protocol for next steps with rescreening or audiological referral 3 4 Device Hardware 3 4 1 On Off Switch The on ...

Страница 13: ... saved data on the device 3 4 3 Device Cable Connectors Multiple cables can be connected to the device This includes The Acoustic Transducer Assembly ATA Patient Cable and the Multi Data Cable for connecting the label printer USB communication cable and power cable for charging purpose For further information see section 6 Accessories The sockets can be used as described in Table 1 Socket Cable OD...

Страница 14: ...s automatically and completes within about 5 8 hours The battery status can be derived from the status indicator from empty to full The battery status icon symbol charging Docking Station and the Multi Data Cable will feature a LED indicating when the device is charging 3 5 Device Functions 3 5 1 User Management With the ALGOLink software you can activate or de activate the user management on your...

Страница 15: ...n be conducted and patient data can be entered and saved simultaneously This may be helpful e g for quickly testing a sleeping child if there is no time to enter the patient data in advance When conducting test in Speed Screen mode always make sure that you assign the test data to the correct patient Patient Data can also be added retrospectively once the test is complete by going to Patient List ...

Страница 16: ...e touch display When done confirm by tapping the check mark You ll be automatically asked if you want the patient added to the To Do List Once a Patient has been saved to the Patient and or To Do list following options are available Start Screen Select Protocol and View Results ...

Страница 17: ... device online help by tapping the question mark in the patient screen When adding Patient to the To Do List you can create your individual work list for each day Either load your To Do list using the ALGOLink PC Software onto your device or choose from the patient database on your ALGO 7i device and tap on the add patient button in the footer of the Patient Details screen When using the To Do lis...

Страница 18: ...e the device to your needs The device settings can be reached via Settings Tab with the gearwheel symbol on the main screen The following device settings are available Device Management date and time format Display Options Language sound key click result sound display brightness power options keyboard preferences Data Management Patient Removal Factory Presets Test preferences To Do List Removal C...

Страница 19: ...etal bar of your Check Kit Then plug in your ATA Cable in the grey socket and connect to the left and right opening of the Check Kit Tap the Cable Check button and follow the on screen instructions Please note Please do not run this test without connecting cables to the ALGO 7i Check Kit If your ATA Cable fails the Cable Check Screening will be disabled with this particular cable until a successfu...

Страница 20: ...e following aspects Ambient noise levels should be minimized to avoid interference with screening Myogenic interference from a restless baby or environmental factors will affect the screening and should be kept to a minimum For ABR measurements also make sure to test in an environment with low electromagnetic disturbance from electronic devices e g computers lights other electronic medical devices...

Страница 21: ...preparation gel such as NuPrep If a skin preparation gel is used be sure to remove it with damp gauze leaving the skin moist before applying the sensors Do not prepare skin or apply Jelly Tab sensors to damaged or compromised skin Always remove and dispose of the Jelly Tab sensors when screening is completed Jelly Tab sensors are designed for single patient use Do not reuse Do not use damaged or e...

Страница 22: ... Roll the earphone from the back of the ear to the front as you attach it to the baby The earphone must completely enclose the external ear and form a good seal all the way around Ensure that the transducer is in the front i e towards the baby s face This ensures that the screening stimulus is directed into the infant s ear Avoid applying Flexicouplers to hair if possible Ensure that the colored t...

Страница 23: ...ening tap New Patient and enter the patient information and select start screen or select protocol and start screen depending on your device settings If you want to start screening immediately and enter Patient data during screening touch Speed Screen You will be directed to the Screening display and measurement will automatically start if ATA Cable and Patient Cable are connected properly to the ...

Страница 24: ... permanent pressure on the touch screen during startup of the device Check if there is a particle between the display and the surrounding display frame Remove the particle with a small and soft tool e g paper strip Error message Calibration service interval expired The error message appears if the calibration interval of a transducer or the service interval of the device has expired Please send th...

Страница 25: ... safety in operation reliability and capability of the device or accessory if any service activities or repairs were conducted by a non authorized service partner see also section 7 Warranty If in doubt please contact Natus before commissioning a service activity or repair Please send the device or accessory in its original packaging to your distributor 4 2 Routine Maintenance and Calibration To e...

Страница 26: ...orage In addition to the annual metrological inspection a regular visual inspection and a regular check for correct operation of the device and its accessories is recommended Guidelines for routine inspections are provided e g in DIN EN ISO 8253 1 for pure tone audiometry Please follow local regulations or guidelines 4 3 Repair If a defect of any kind is suspected or calibration of cables is due N...

Страница 27: ...ive components Never attempt to clean the sound apertures on the transducer body with cleaning solution or by inserting an object in the sound apertures Do not immerse the device into liquid and ensure that no liquid gets inside the device Dry the device with a lint free cloth after cleaning Disposable accessories Jelly Tab sensors and Flexicouplers must be replaced between patients to avoid cross...

Страница 28: ... AP1300 no Related accessories printout paper rolls Multi Data Cable USB Charging Label Printer Modem Connection no 0 2 m 8 Modem no Transportation bag no PC software no Power supply unit Friwo FW7662 no 1 83 m 72 Docking Station no Maximum cable length rounded in metrics units The above list of accessories may be subject to change Accessories may be available only upon request may be replaced by ...

Страница 29: ...s and cosmetic damages e g scratches Opening the device case or any accessory housing voids this warranty This warranty includes material and labor costs in accordance with the manufacturer specifications Natus Medical reserves the right to credit repair or replace with a new or refurbished product an in warranty device or accessory Warranty repairs for the ALGO 7i are handled in the same manner a...

Страница 30: ......

Страница 31: ...r plug Likewise this is true for any accessory with a separate power supply e g label printer The device needs to be operated in a quiet environment so that measurements are not influenced by ambient noises This may be determined by an appropriately skilled person trained in acoustics DIN EN ISO 8253 1 section 11 defines maximum ambient noise levels for audiometric hearing testing If not followed ...

Страница 32: ... device Do not use any power supply other than the ones defined in section 9 Technical Specifications The use of alternate power supplies designed for other electronic devices such as notebook computers or printers may cause damage to the device Likewise using the ALGO 7i power supply on other types of devices may cause damage to those devices Avoid accidental contact between connected but unused ...

Страница 33: ...teristics of the sender Failure to do so may result in a reduction of device performance Use of other accessories than the ones specified or provided by PATH MEDICAL may result in higher electromagnetic emission or reduced immunity to interference of the device and may result in improper device operation 8 5 Accessories The Flexicouplers and Jelly Tab sensors are marked single use only and must be...

Страница 34: ...g out of a socket always pull at the plug and not at the cable to avoid cable break Do not expose the label printout to sunlight or heat Printing on thermal paper fades with exposure to light or heat 8 6 Waste Disposal The device includes a rechargeable lithium ion battery pack Replacement of the battery pack must be completed by an authorized service partner The service partner is responsible for...

Страница 35: ... 2 EMC DIN EN 60601 1 4 PEMS DIN EN 60601 1 6 and DIN EN 62366 usability DIN EN 60601 2 40 AEP equipment DIN EN 60645 3 short term test signals DIN EN 60645 7 ABR DIN EN 62304 software lifecycle 9 2 Device Characteristics Device dimension ca 209 x 98 x 52 mm 8 22 x 3 86 x 2 05 Device weight including battery pack ca 500 g Display properties 240 x 320 pixel graphic LCD 3 5 Maximum power consumption...

Страница 36: ...0 to 40 C 50 to 104 F Relative air humidity 20 to 90 non condensing Barometric pressure 70 to 106 kPa In the following cases a transducer recalibration at the point of use is recommended Air pressure at point of calibration pc Air pressure at point of use pu 98 to 104 kPa 92 kPa 92 to 98 kPa pc 6 kPa 92 kPa pc 6 kPa or pc 6 kPa See also DIN EN 60645 1 5 3 and Soares et al Audiometer Correction fac...

Страница 37: ......

Страница 38: ...blishments including those in residential environments and those that are directly connected to a public power network that also supplies buildings used for residential purposes Emission of harmonic components according to IEC 61000 3 2 Class A Emission of voltage fluctuation flicker according to IEC 61000 3 3 Compliant Table 5 Compliance with electromagnetic emission guidelines and resulting requ...

Страница 39: ...ironment The user must take care that the device is used in an environment with minimum distances to potential radiators as described in Table 7 Tests for immunity to interference IEC 60601 test level Concurrent level Electromagnetic environment Conducted high frequency disturbance according to IEC 61000 4 6 3 V 150 kHz 80 MHz 6 V ISM frequencies 3 V 6 V Portable and mobile radio units shall not b...

Страница 40: ... View Road Middleton WI 53562 USA Toll free 1 800 303 0306 Telephone 1 650 802 0400 Fax 1 650 802 8680 E mail technical_service natus com www natus com PATH MEDICAL GmbH Landsberger Straße 65 82110 Germering Germany Contact information from distributor service partner ...

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