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Safety during Use

Operating Conditions

5

WARNING
Risk of electromagnetic interference through the use of portable RF communication equipment

If portable RF communication devices (including peripheral devices such as antenna cables and

external antennae) are operated closer than 30 cm (12 inches) from this device, this can result in a

reduction in its performance. This applies even when using associated cables.

When operating portable RF communication devices (including peripheral devices such as

antenna cables and external antennae), keep such devices at a distance of at least 30 cm

(12 inches) from this device.

Only operate the device in rooms that fulfill the following conditions:

No danger of explosion

Suitable for medical purposes

Class I power outlet

Place the device and its components on a flat, dry surface. It should be placed so that it cannot slip,

even while the cables are connected. Also ensure that it is protected from liquids and moisture, and

that the patient only comes into contact with the programming head. In addition to this, ensure that the

power plug of the power adapter is easily accessible and can be pulled out of the outlet at all times. Do

not touch any plug connections such as Redel connectors and the patient 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 requirements of IEC 60364‑7‑710:2002 group 1.

The power plug of the power adapter goes directly into a permanently installed mains supply

outlet. No portable multiple socket outlets or extension cables should be used.

The power plug of the power adapter must be easily accessible at all times in order to be able to

immediately disconnect the device from the mains supply.

When used in combination with other devices, no portable multiple socket outlets may be used.

Only power supply adapter authorized by BIOTRONIK may be used.

To disconnect the device from the mains supply, pull its power plug out from the outlet.

Cable and plug connections

Replace the device or its components immediately if there is any visible, even minor damage to the

cables.

Lay all cables in such a way that they pose no danger of tripping over them and that any tensile

forces that may occur can be safely buffered.

Ensure that the contacts of all connections and plugs are clean. Dirty contacts can lead to signal

distortions.

Ensure that there is no condensation on the plugs or in the connector ports. If condensation is

present, dry it before use.

Do not force plugs into the connector ports and do not pull on the cable to release the lock when

disconnecting the plugs.

Содержание BIOwand

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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