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W&H S-NW, Инструкция по эксплуатации

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Technical data

Classification according to Paragraph 6 of the General Specifications for the Safety of Medical Electrical Device
according to IEC 60601-1/ANSI/AAMI ES 60601-1

S-NW / S-N2 / S-N1 are waterproof according to IPX8, 1 m depth of immersion,

1 hour (water-tight in accordance with IEC 60529)

Pollution level: 

2 

Altitude: 

up to 3,000 m above sea level

S-NW / S-N2 / S-N1 are approved for operation in potentially explosive atmospheres.

AP

Содержание S-NW

Страница 1: ...Instructions for Use Foot control variable S NW S N2 S N1...

Страница 2: ...Connecting and disconnecting the CAN dongle 18 Description of CAN dongle 19 Connecting and disconnecting the SPI dongle 20 Description of SPI dongle 21 Assistance with pairing problems 22 7 Foot contr...

Страница 3: ...3 Symbols WARNING if persons could be injured ATTENTION if property could be damaged General explanations without risk to persons or property in the Instructions for Use Foot control...

Страница 4: ...CM indicates compliance with the Australian and New Zealand electrical safety EMC EME and telecommunications requirements on the foot control S NW Category AP equipment AP This medical device does not...

Страница 5: ...s Do not dispose of with domestic waste Catalogue number Serial number Date of manufacture Data Matrix code for product information including UDI Unique Device Identification CE marking with identific...

Страница 6: ...care Keep dry Permitted temperature range Humidity limitation Der Gr ne Punkt The Green Dot trademark of Duales System Deutschland GmbH Trademark of RESY OfW GmbH for identification of recyclable tra...

Страница 7: ...ients are of paramount importance to us Observe the safety notes Intended use Foot control for operation of medical electrical equipment Misuse may damage the foot control and hence cause risks and ha...

Страница 8: ...be used in accordance with these Instructions for Use and with the instructions for use of the drive unit The foot control has no components that can be repaired by the user Modifications or repairs...

Страница 9: ...F communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to the medical device Otherwise degradation of the performan...

Страница 10: ...EF 30286xxx 30287xxx Amadeo Medical M UK 1023 M UK 1015 M UK 1010 S N1 REF 05083300 SI 95 Implantmed DU900 OsseoSetTM 100 Frios Unit S SA 200 SA 200 C Elcomed S N1 REF 05046200 SI 923 SI 915 Implantme...

Страница 11: ...11 Foot control S NW 3 disposable batteries AA Mignon LR6 1 5V Not included Scope of delivery...

Страница 12: ...ace the foot control if the resistance of the pedal is noticeably reduced Never touch the patient and the connections for the foot control on the control unit simultaneously The ESD spring contact on...

Страница 13: ...out if patient and user have implanted systems before using the medical device and consider the application Weigh the risks and benefits Keep the medical device away from implanted systems Make approp...

Страница 14: ...Use only high quality disposable alkaline AA Mignon LR6 1 5 V batteries Risk of explosion if the wrong type of battery is used Do not mix new old or different types of disposable batteries Do not use...

Страница 15: ...15 5 Attaching detaching the locator Attaching and detaching the locator Push it right in until the locator reaches the stop Pull the locator out...

Страница 16: ...hread to remove the batteries Open battery compartment Remove batteries Inserting and replacing batteries Lock the battery compartment Insert batteries Reposition the red thread before inserting batte...

Страница 17: ...Foot control S NW Do not use sharp tools Firmly squeeze the O ring between your thumb and index finger so that it forms a loop Pull off the O ring Push the new O ring on in its place Replacing the O r...

Страница 18: ...lug in the CAN dongle Pay attention to the positioning Press the side lock and remove the CAN dongle Foot control S NW Connecting CAN dongle Removing CAN dongle Connecting and disconnecting the CAN do...

Страница 19: ...tmed instructions for use and follow the directions Press and hold the green and orange buttons simultaneously on the S NW foot control for at least 3 seconds Disable pairing Press and hold the green...

Страница 20: ...I dongle Pay attention to the positioning Plug in the SPI dongle or disconnect the SPI dongle from the control unit Attach the SPI dongle to the irrigant support or remove the SPI dongle from the irri...

Страница 21: ...the button on the SPI dongle for 4 seconds LED indicator flashes SPI dongle is in pairing mode for 30 seconds Press and hold the green and orange buttons simultaneously on the S NW foot control LED f...

Страница 22: ...foot control Eliminate any sources of interference e g brush motors mobile telephones radios WLAN Replace the pairing and repeat the pairing process Remove and replace the batteries If the pairing pro...

Страница 23: ...23 7 Foot control S N2 S N1 Pay attention to the positioning Plug in the foot control S N2 S N1 or disconnect the foot control from the control unit Connecting disconnecting...

Страница 24: ...nes for cleaning Wear protective clothing safety glasses face mask and gloves The foot control is sealed and may be wiped clean The foot control is not approved for automated cleaning thermo washer di...

Страница 25: ...rrent Measurement of ESD capacity Visual inspection of the ESD spring contact on the bottom of the foot control electrostatic discharge Function test with check to see if the maximum speed can be reac...

Страница 26: ...pare parts Use only original W H accessories and spare parts or accessories approved by W H Suppliers W H partners Link https www wh com 07759700 CAN dongle 07795800 SPI dongle 04653500 Locator for fo...

Страница 27: ...10 C to 40 C 50 F to 104 F Air Humidity in operation 15 to 80 relative non condensing Foot control S NW S N2 S N1 Power supply 3 disposable batteries AA Mignon LR6 1 5V Dimensions in mm height x width...

Страница 28: ...trical Device according to IEC 60601 1 ANSI AAMI ES 60601 1 S NW S N2 S N1 are waterproof according to IPX8 1 m depth of immersion 1 hour water tight in accordance with IEC 60529 Pollution level 2 Alt...

Страница 29: ...isposal Ensure that the parts are not contaminated on disposal Follow your local and country specific laws directives standards and guidelines for disposal Medical device Waste electrical equipment Pa...

Страница 30: ...anufacturing defects within a warranty period of twenty four months from the date of purchase Accessories and consumables batteries O ring locator for foot control are not covered by the warranty We a...

Страница 31: ...7 874990 f 44 1727 872254 E Mail technical uk wh com W H Impex Inc 6490 Hawthorne Drive Windsor Ontario N8T 1J9 Canada t 1 800 2656277 1 519 9446739 f 1 519 9746121 E Mail service ca wh com W H Impex...

Страница 32: ...32 Manufacturer s declaration...

Страница 33: ...33 Manufacturer s declaration...

Страница 34: ...34 Manufacturer s declaration...

Страница 35: ...35 Manufacturer s declaration...

Страница 36: ...Form Nr 50882 AEN Rev 005 02 08 2019 Subject to alterations Manufacturer W H Dentalwerk B rmoos GmbH Ignaz Glaser Stra e 53 5111 B rmoos Austria t 43 6274 6236 0 f 43 6274 6236 55 office wh com wh com...

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