English - BIOSENSORS BIOTRANS Instrucciones De Uso

English

Overinfusion
Excessive fluid may be infused into the patient if the bag pressure is greater than 300 mmHg. This may result in fluid overload and/or a potentially harmful
increase in blood pressure.
Abnormal Pressure Readings
Pressure readings can change quickly and dramatically because of loss of proper calibration, loose connections, or air in the system.
CONTRAINDICATIONS
DO NOT use kits equipped with a Flush Device for monitoring intramuscular or intracranial pressures.
WARNING
• This product is designed for single use only. DO NOT resterilize or reuse Kit components, as cleaning and sterilization may result in damage.
• This device is intended for single patient use only.
• DO NOT resterilize and/ or reuse this device, as this can compromise its performance and can lead to device failure and procedure complications with
severe injury or patient death. Reuse and resterilisation bear the risk of cross contamination and patient infection and may also cause transmission of
infectious diseases from patient to patient.
CAUTION
DO NOT use Kit components if package is opened or damaged as contents may lose sterility. The use of non-sterile components may result in patient infection.
Inspect all packages prior to use.
PRECAUTIONS
• DO NOT use the kit components after indicated expiration date on the packaging.
• The product is designed for single use only. DO NOT reuse or resterilise the kit's components.
• DO NOT use kit components if packaging is opened or damaged as contents may loses sterility. Use of non-sterile components may result in patient
infection. Inspect all packages prior to use.
MAINTAINING DEVICE EFFECTIVENESS
Universal Precautions and Sterile Technique should be practiced in accordance with facility protocols and CDC Guidelines during the connection,
disconnection, and exchange of all fluid pathway components. The Pressure Monitoring System should be zeroed/ rezeroed and calibration verified:
• when the system is initially set up
• when the temperature changes by more than 5 C (9 F)
• before any critical measurement
• when height of sensor in relations to patient's heart is altered (rezero only)
• when Dome has been disconnected from Base during monitoring of the patient. In such event, always turn Zero stopcock OFF to patient before reinstalling
Dome on Base following procedures detailed in Section C; then rezero per Section F.
PRECAUTIONS
• Stopcock handles must be positioned in line with ports to be fully ON or OFF. Positioning at 45 angle to ports (or other intermediate angle) is not sufficient
to prevent air embolism, patient bleedback, or fluid path contamination.
• Always check sensor diaphragm for cracks, holes, and tears before installing Dome. Do not use if damaged observed.
• To avoid applying excessive pressure to sensor, ALWAYS place Zeroing Stopcock handle in Monitoring Position (OFF to atmosphere) prior to placing
non-vented caps on Zero Port.
• Do not prime system with catheter attached. Doing so may introduce air to the patient.
• Catheter patency must be verified, and air in the fluid pathway eliminated before connecting Extension Tubing to catheter.
Refer to Section F3 and F4 for troubleshooting procedures and precautions.
INSTRUCTIONS FOR USE
A. MOUNTING BASE POLE MOUNT APPLICATIONS
Following Instructions for Use provided with BIOTRANS™ Reusable Sensor Base, mount BIOTRANS™ Base(s) to IV poles and apply label(s). Position IV pole
with BIOTRANS™ Base(s) in an appropriate location close to patient.
PATIENT MOUNT APPLICATIONS
1. Using sterile technique, carefully open Kit package on a flat work surface. Use inner surface of package as a sterile work site. Tighten all connections.
2. If sensor cable is already connected to monitor cable, thread previously cleaned sensor base through tubular section of protective sheath until entire sensor
base extends beyond tube. (SEE Fig. 3A & 3B). If cables are not connected, connect before proceeding. Sensor cable and adapter junction will now be
protected by sheath.
3. Position base at desired location on patient's arm or wrist and secure in
place by engaging Velcro fastener. (Protected cable will extend up
patient's arm.)
4. Connect required Monitor Adapter Cable to appropriate channel of
monitor. Turn monitor ON.
B. FILLING (PRIMING) THE BIOTRANS™ KITS (For Kits with BIOPORT™
system, refer to Instruction for Use for BIOPORT™ Closed Blood
Sampling System)
CAUTION
All side ports of stopcocks and luer connectors are protected by
white vented caps which are to be left in place until the system is
filled with sterile solution and debubbled.
1. Prepare sterile heparinized flush solution (typically 0.9 N sterile saline
containing 1 or 2 units of aqueous heparin per cc of solution), as
prescribed by a properly licensed practitioner, in a non-vented solution
bag.
a. Evacuate all air from non-vented solution bag and fill IV Administration Set.
DLCK-0011-003 REV. H8 DLCK-0011-003 REV. H8
DLCK-0011-003 REV. A2H8
Sterile Wrist Band
Protective Sheath
Velcro™ Hooks
Patient-Mount
Base
Monitor Adapter Cable
Sensor
Cable
To Pressure
Monitor
Fig. 3A: Insertion of patient-mount base and
monitor adapter cable into sterile protective
sheath.
2
Sterile
Wrist Band
Velcro Type
Hooks
Sterile
Protective Sheath
To Pressure
Monitor
Monitor
Adapter
Cable
Fig. 3B: Attaching Wrist Strap to Patient
Mount Base.