English . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Français . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Deutsch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Español. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Italiano. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Nederlands . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Dansk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Svenska . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Ελληνικά. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
English
Pressure Controller Kit
PC2K and PCCVR
Carefully read these instructions for use, which address the warnings, precautions, and residual risks for this
medical device.
For figures, see Figure 1 on page 82 through Figure 8 on page 83.
1.0 Description
The pressure controller kit consists of a pressure controller (PC2) and accompanying band (PC2B). The pressure controller can be used with the EV1000 clinical platform NI
and HemoSphere advanced monitoring platform to noninvasively measure blood pressure and key hemodynamic parameters using a compatible Edwards finger cuff
wrapped around the finger. The pressure controller is worn on the patient's wrist and connects to the compatible Edwards noninvasive monitoring system, heart
reference sensor and compatible Edwards finger cuff(s) (Figure 1 on page 82).
A pressure controller cover is available as an accessory. The pressure controller cover secures the heart reference sensor into the pressure controller.
Device performance, including functional characteristics, have been verified in a comprehensive series of testing to support the safety and performance of the device for
its intended use when used in accordance with the established Instructions for Use.
Edwards, Edwards Lifesciences, the stylized E logo, EV1000, and HemoSphere are trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
DIRECTORY
Português . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Česky . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Magyar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Polski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Slovensky. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Norsk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Suomi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Български. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Română . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
1
Eesti . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Lietuvių . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Latviešu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Türkçe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Русский . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Srpski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
简体中文 . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
한국어 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
日本語 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79