Edwards HemoSphere HEMPSC100

To Next Page

HemoSphere Pressure Cable

Carefully read these instructions for use and all

contained warnings and cautions before using this

product. Refer to the HemoSphere advanced monitor

operator’s manual, available at eifu.edwards.com,

forcomprehensive monitoring procedures.

Description

The HemoSphere pressure cable is a reusable device

that connects with a compatible monitor on one end

④ and any approved single Edwards disposable

pressure transducer (DPT) or sensor on the other end

① to continuously measure standard intravascular

pressure values or cardiac output (CO), pulse rate

(PR), stroke volume (SV), and stroke volume variation

(SVV) when using an Edwards arterial pressure based

cardiac output (APCO) sensor. Whenconnected to a

Acumen IQ or FloTracIQ sensor, additional parameters

are available that provide theclinician with

information on the likelihood ofahypotensive event.

Note: The expected useful life of the HemoSphere

pressure cable is 5 years from date of manufacture,

at which point the cable should be replaced and

returned to EdwardsLifesciences. Please contact

Technical Support or your local Edwards

representative for further assistance.

Compatible Sensors

The HemoSphere pressure cable is intended to be

used in combination with a compatible monitor,

anEdwards approved DPT or sensor, and

compatible pressure monitoring catheters to

measure intravascular pressure. Edwards approved

sensors include the TruWaveDPT, FloTrac,

AcumenIQ, and FloTracIQ sensors.

Indications for Use

The HemoSphere advanced monitor when used with

the HemoSphere pressure cable is indicated for use in

critical care patients in which the balance between

cardiac function, fluid status, vascular resistance and

pressure needs continuous assessment. It may be used

for monitoring hemodynamic parameters in

conjunction with aperioperative goal directed

therapy protocol in ahospital environment. Refer

tothe Edwards FloTrac sensor, Acumen IQ sensor,

FloTracIQ sensor, and TruWaveDPT indications for

use statements for information on target patient

population specific to the sensor/transducer being used.

The EdwardsLifesciences Acumen Hypotension

Prediction Index (HPI) feature provides the clinician

with physiological insight into a patient’s likelihood

offuture hypotensive events (defined as mean arterial

pressure < 65 mmHg for at least one minute in

duration) and the associated hemodynamics. The

Acumen HPI feature is intended for use in operating

room (OR) patients receiving advanced hemodynamic

monitoring. The Acumen HPI feature is considered

tobe additional quantitative information regarding

the patient’s physiological condition for reference

onlyand no therapeutic decisions should be made

based solely on the Acumen Hypotension Prediction

Index (HPI) parameter.

Refer to the Intended Use statement and to tables2

and 3 for a complete list of measured and derived

parameters available for each patient population.

Intended Use

The HemoSphere advanced monitoring platform is

intended to be used by qualified personnel or trained

clinicians in a critical care environment in a hospital

setting. The HemoSphere advanced monitoring

platform is intended for use with compatible

Edwards oximetry and Swan-Ganz catheters, and

pressure monitoring sensors and catheters.

A comprehensive list of parameters available while

monitoring with the HemoSphere advanced

monitor and a connected HemoSphere pressure

cable or connected HemoSphere pressure cable and

oximetry cable are listed in tables 2 and 3.

Warnings

Compliance to IEC 60601-1 is only maintained when

the HemoSphere pressure cable (applied part accessory,

defibrillation proof) is connected to a compatible

monitoring platform. Connecting external equipment

Edwards, EdwardsLifesciences, the stylized E logo,

Acumen, Acumen HPI, Acumen IQ, FloTrac, FloTracIQ,

HemoSphere, HPI, Hypotension Prediction Index,

Swan, Swan-Ganz, and TruWave are trademarks

ofEdwardsLifesciences Corporation. All other

trademarks aretheproperty of their respective

owners.

HMS-1019

Figure 1. HemoSphere Pressure Cable (Model HEMPSC100)

English

The HemoSphere pressure cable is a reusable device designed to connect with a compatible monitor and an approved single-use pressure transducer (DPT) or sensor. This connection enables continuous measurement of standard intravascular pressure values, cardiac output (CO), pulse rate (PR), stroke volume (SV), and stroke volume variation (SVV) when used with an Edwards arterial pressure-based cardiac output (APCO) sensor. When connected to an Acumen IQ or FloTrac IQ sensor, additional parameters are available to provide clinicians with information on the likelihood of a hypotensive event.

Function Description:

The HemoSphere advanced monitor, when used with the HemoSphere pressure cable, is indicated for use in critical care patients where continuous assessment of cardiac function, fluid status, vascular resistance, and pressure is necessary. It can be used for monitoring hemodynamic parameters in conjunction with a perioperative goal-directed therapy protocol in a hospital environment. The Edwards Lifesciences Acumen Hypotension Prediction Index (HPI) feature provides physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and associated hemodynamics. The Acumen HPI feature is intended for use in operating room (OR) patients receiving advanced hemodynamic monitoring. It is considered additional quantitative information regarding the patient's physiological condition for reference only, and therapeutic decisions should not be made solely based on the HPI parameter.

Important Technical Specifications:

Cable Length: 3 m (10 ft)
Operating Conditions:
- Temperature: 10 to 32.5 °C
- Humidity Range: 20 to 90% non-condensing
- Altitude (Atmospheric Pressure): 0 m/0 ft (1013 hPa) to 3048 m/10,000 ft (697 hPa)
- IP Rating: IPX4
Parameter Measurement Specifications:
- FloTrac Cardiac Output (CO):
  - Display Range: 1.0 to 20 L/min
  - Reproducibility: ±6% or 0.1 L/min, whichever is greater
- Blood Pressure:
  - Live Pressure Display Range: -34 to 312 mmHg
  - MAP/DIA/SYS Display Range: 0 to 300 mmHg
  - CVP Display Range: 0 to 50 mmHg
  - MPAP Display Range: 0 to 99 mmHg
  - Accuracy: ±4% or ±4 mmHg, whichever is greater, from -30 to 300 mmHg
  - Bandwidth: 1-10 Hz
- Pulse Rate (PR):
  - Accuracy: Arms ≤ 3 bpm

Usage Features:

The HemoSphere pressure cable is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. The HemoSphere advanced monitoring platform is intended for use with compatible Edwards oximetry and Swan-Ganz catheters, and pressure monitoring sensors and catheters.

Setup Procedure:

Connect the HemoSphere pressure cable to a compatible monitor at the end indicated by ④ in Figure 1.
Set up and initiate the compatible monitor.
Insert the appropriate color insert at ② to indicate the monitored pressure type. Colors correspond to:
- Red for arterial pressure (AP)
- Blue for central venous pressure (CVP)
- Yellow for pulmonary artery pressure (PAP)
- Green for cardiac output (CO)
Connect the pressure sensor to the pressure cable. The pressure cable LED surrounding the zero button at ③ will flash green, indicating that the pressure sensor is detected. A yellow light indicates a sensor fault condition; if this occurs, refer to the monitor screen for specific fault condition details.
Follow all instructions found in the pressure monitoring catheter IFU for catheter preparation and insertion procedures. The HemoSphere pressure cable must be zeroed before monitoring.

Zeroing Procedure:

To initiate the zeroing process, press and hold the zero button indicated by ③ in Figure 1, or initiate the zeroing process on the connected monitor screen. Refer to the compatible monitor operator's manual for on-screen zeroing instructions.
Level the sensor stopcock valve (vent port) to the patient's phlebostatic axis position according to the instructions for use.
Open the stopcock valve to measure atmospheric conditions.
Press and hold the pressure cable zero button or the on-screen button to complete the zeroing process. The zero button LED will turn off when properly zeroed.
Confirm stable zero pressure and turn the stopcock such that the sensor is reading patient intravascular pressure.

MRI Information:

The HemoSphere pressure cable is MR unsafe and should not be used in an MR environment. The device contains metallic components which can experience RF-induced heating in the MRI environment.

Maintenance Features:

Cleaning: The pressure cable is a reusable device that can be surface cleaned per hospital aseptic procedures. It has been shown to handle cloth wipe-down using 70% isopropyl alcohol, 2% glutaraldehyde, 10% bleach solution, or quaternary ammonium solution.
Drying: Disconnect the pressure cable from the monitor to air dry the transducer connector. To blow dry the transducer connector, use clean, dry wall air, canned air, or CO2 aerosol for at least two minutes. If left to dry under room conditions, allow the connector to dry for two days before using.
Inspection: It is recommended to inspect the HemoSphere pressure cable periodically for signs of damage. Check the condition of the cable and replace it if any of the following are present: exposed wire, splits, cracks, or signs of stress.
Disconnection: When unplugging the HemoSphere pressure cable from a compatible monitor or sensors from the pressure cable, always pull at the connection site. Do not pull from cables or use tools to disconnect.
Sterilization: Do not steam, radiate, or EtO sterilize the pressure cable.
Storage: Store in a cool, dry place in original packaging to prevent damage. Avoid coiling the cable against its natural orientation or coiling it tightly.
- Storage Temperature: -18 to 45 °C
- Relative Humidity: 90% non-condensing at 45 °C
- Altitude: 0 to 20,000 feet (6096 m)

Warnings and Precautions:

Compliance to IEC 60601-1 is only maintained when the HemoSphere pressure cable is connected to a compatible monitoring platform. Connecting external equipment or configuring the system in a way not described in these instructions will not meet this standard.
Do not modify, service, or alter the product in any way.
Do not use if the package or the pressure cable is damaged.
Do not apply excessive force to the pressure cable zero button to prevent cable damage.
Do not use any other cleaning agents, spray, or pour cleaning solution directly on the pressure cable.
The device contains electronics; handle with care.
Do not immerse.
Excessive dropping of the HemoSphere pressure cable may result in cable damage and/or malfunction.