BIOTRONIK BIOwand Technical Manual Download Page 20

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Appendix

Legend for the Label

CE mark

Caution: Federal law (USA) restricts this device to sale by or on the order of physician.

Device contains materials that must be correctly disposed of in accordance with environ-

mental protection regulations. The European Directive 2012/19/EU on waste electrical and

electronic equipment (WEEE 2) applies. Return devices that are no longer used to

BIOTRONIK.

BIOwand

Programming head (BIOwand PGH)

Signal transmission

Neurostimulator from BIOTRONIK

Summary of Contents for BIOwand

Page 1: ...BIOwand Device for wireless communication with the BIOTRONIK stimulator Technical Manual 452051 Revision C DRAFT 2021 02 26...

Page 2: ...istributor BIOTRONIK Inc 6024 Jean Road Lake Oswego OR 97 035 5369 Tel 800 547 0394 24 hour Fax 503 635 9936 marketing biotronikusa com BIOTRONIK SE Co KG All rights reserved Specifications subject to...

Page 3: ...tus Indicator LED 11 Power Adapter On Off Light Indicator LED 11 Bluetooth Status Indicator LED 11 Telemetry Status Indicator on the Programming Head 11 Setting up the Device 12 Connecting the Program...

Page 4: ...cation are identical to those of the SCS system Required expertise The use of the device and this technical manual are intended for field representatives of BIOTRONIK who are familiar with the followi...

Page 5: ...aulty operation of the device Only use accessories authorized by BIOTRONIK Precautions Risk of electromagnetic interference The use of this device close to or in direct contact with other devices shou...

Page 6: ...ices and components Liquids Never connect a damp or wet device to the mains supply and never use damp or wet components Protect the device and its components from the accidental ingress of liquids and...

Page 7: ...nt at the same time Power supply The device is operated via the provided power adapter The electrical outlet must fulfill the following conditions The mains installation at least fulfills the requirem...

Page 8: ...formed according to IEC 60601 1 2 2014 Section Test Test level 7 1 EN 55011 CISPR 11 Conducted interference emissions Group 1 Class B EN 55011 CISPR 11 Radiated emission 7 2 1 IEC 61000 3 2 Harmonic d...

Page 9: ...promise the function of the device in certain cases This kind of device malfunction should be considered as a possible cause if the following is observed The device switches on by itself The device di...

Page 10: ...ollowing regulations are applicable to the device and its components Disconnect the power plug from the outlet before cleaning and or disinfecting Use lint free soft cloths Clean the housing with a da...

Page 11: ...Owand PGH 3 Power adapter FW8000M 12 with on off light indicator and power plug 4 Plug for connecting the power adapter to the device BIOwand Device 5 Programming head connection BIOwand PGH 6 Pair di...

Page 12: ...manual Position for the guide cam of the Redel plug Device contains materials that must be correctly disposed of in accordance with environ mental protection regulations The European Directive 2012 19...

Page 13: ...icator LED The status indicator for pairing disconnecting the Bluetooth connection shows the following device statuses LED behavior and color Device status LED does not indicate any behavior There is...

Page 14: ...he power adapter FW8000M 12 and to switch on the device proceed as follows 1 Select the appropriate power plug adapter for your region for the enclosed power adapter 2 Insert the required power plug a...

Page 15: ...ghts up blue continuously Disconnecting the BIOwand Bluetooth connection To disconnect the Bluetooth connection proceed as follows 1 Press the Pair Disconnect key of the BIOwand to disconnect the Blue...

Page 16: ...g head BIOwand PGH is connected 1 Check whether the programming head BIOwand PGH has been correctly connected 2 Connect a programming head BIOwand PGH An internal error has occurred 1 To switch off th...

Page 17: ...essure 700 1060 hPa Operation at altitudes Up to 3 000 m Power supply to the device Operation with power adapter FW8000M 12 Physical properties Category Design Dimensions W x D x H 120 x 150 x 42 8 mm...

Page 18: ...complete system device power adapter and programming head Country related information International radio certification Telemetry information for Australia This device is in compliance with the Austr...

Page 19: ...ocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult...

Page 20: ...ins materials that must be correctly disposed of in accordance with environ mental protection regulations The European Directive 2012 19 EU on waste electrical and electronic equipment WEEE 2 applies...