Invuity PhotonBlade Скачать руководство пользователя страница 1 | Manualshive

Страница: 1 / 12

Invuity PhotonBlade Скачать руководство пользователя страница 1

IFU 12296 Rev C

Invuity Customer Service: 866.711.7768

PhotonBlade

®

Instructions for Use

MANUFACTURER

Invuity, Inc.
444 De Haro Street
San Francisco, CA 94107 USA
Tel: 866.711.7768

www.invuity.com

Consult Instructions for Use and Symbols Glossary on

this website: www.invuity.com/documentlibrary

1
2
3
...
»

Содержание PhotonBlade

Страница 1: ...6 711 7768 PhotonBlade Instructions for Use MANUFACTURER Invuity Inc 444 De Haro Street San Francisco CA 94107 USA Tel 866 711 7768 www invuity com Consult Instructions for Use and Symbols Glossary on this website www invuity com documentlibrary ...

Страница 2: ...lean the device electrode during the procedure Do not use sharp or abrasive objects such as a scratch pad on the PhotonBlade as it may damage the device After use dispose of the PhotonBlade and the battery according to hospital procedures and in accordance with local state and federal laws and regulations Product Use Based on the desired tissue effect the lowest energy settings should be used It i...

Страница 3: ...prevent tissue build up on the electrode However the blade may be held stationary to spot coagulate The blade should be carefully cleaned as tissue build up occurs Only contact the patient with the blade of the device Do not insert the device into tissue beyond the blade as unintended injury or damage to the device may occur Only use CR123A 3V batteries for the illumination function Safety Do not ...

Страница 4: ... to the surgical drape or a dry non conductive area away from the patient to prevent unintended contact with patient or user Avoid fluid contact with the device hand switch as this may cause damage to the device Do not use the PhotonBlade on small appendages as monopolar electrosurgery may cause thrombosis or unintended tissue injury Follow all surgical fire precautions and hospital safety procedu...

Страница 5: ...ge greater than 3000V Consult the user manual of the electrosurgical unit ESU to determine the voltage output characteristics for different power settings and modes Table 1 lists CUT and COAG power settings and modes used with the PhotonBlade device in combination with the ConMed System 5000 and Valleylab FX C ESUs to conduct in vitro testing that confirmed device performance in the specified tiss...

Страница 6: ... the handswitch The Cut button is the most distal on the hand piece 5 To coagulate press and hold the blue button continuously on the handswitch The Coag button is the middle button on the hand piece 6 To turn the illumination on first ensure the device is not contacting tissue then press the white button on the handswitch once The illumination button is the most proximal on the hand piece 7 To tu...

Страница 7: ...d toward the connector pins d Dispose of the used battery according to hospital procedures and in accordance with local state and federal laws and regulations e Close the battery door and plug the connector back into the ESU Note The Cut and Coag functions of the device operate independently of the illumination If the illumination decreases or stops there is no effect on the Cut and Coag functions...

Страница 8: ...munity The Invuity PB1 PhotonBlade is intended for use in the electromagnetic environment specified below The customer or user of the Invuity PB1 PhotonBlade should ensure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance ESD IEC 61000 4 2 6kV Contact 8kV Air 6kV Contact 8kV Air Floors should be wood concrete or ceramic ...

Страница 9: ...ally with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Invuity PB1 PhotonBlade is used exceeds the applicable RF compliance level above the Invuity PB1 PhotonBlade should be observed to verify normal operation If abnormal performance is observed additio...

Страница 10: ...rwise refurbish any used product The foregoing limited warranty and limited obligation of replacement is void and of no effect in the event that there is any modification made to the medical device or the medical device is used for any purpose other than its intended purpose LIMITATION OF LIABILITY INVUITY DOES NOT ACCEPT LIABILITY TO CUSTOMER OR ANY THIRD PARTY BEYOND THE REMEDIES EXPRESSLY SET F...

Страница 11: ...pect the device and DO NOT USE the device if there are breaks chips cracks scratches tears or missing insulation on the blade or telescoping shaft of the device DO NOT activate energy unless the active edge of the blade is in direct contact with tissue Failure to ensure the active edge of the blade is in direct contact with target tissue while activating energy could result in patient injury inclu...

Страница 12: ...tonBlade PRINTING INSTRUCTIONS Print in house or at an approved supplier Do not print Revision History or Printing Instructions pages page 11 12 Print double sided booklet style in black ink on white paper Fold in booklet folded size is 8 5 in x 5 5 in REF and staple fold ...

Отзывы:

Нет отзывов