BIOSENSORS BIOTRANS Instrucciones De Uso página 7

(7) If overdamped signal is still observed, check System as per above instructions or facility protocols until problem is resolved.
PACKAGING AND STERILITY
BIOTRANS™ Pressure Monitoring Kits is supplied sterile and non-pyrogenic if package is undamaged or unopened. Do not use if package is opened or
damaged. BIOTRANS™ Pressure Monitoring Kits are for single use only. Do not clean or resterilize used BIOTRANS™ Kits.
STORAGE
Biosensors BIOTRANS™ Pressure Monitoring System should be stored in dry location with the protective cap on diaphragm and protective adapter cap in
place.
SHELF-LIFE
The recommended shelf-life is indicated on each package.
PRODUCT SPECIFICATIONS
Note: The Product Specification is a reference for BIOTRANS™ Reusable Sensor Base which is provided separately and not included in BIOTRANS™
Pressure Monitoring Kit. The same Product Specification is provided in Instruction for Use of BIOTRANS™ Reusable Sensor Bases.
Environmental Performance
Storage Temperature
Operating Temperature
Humidity
Operating Atmospheric Pressure
Mechanical Specifications
Pressure Range
Overpressure Withstand
Mounting
Safety Features
Risk Current
Defibrillation Withstand
* from 15 °C to 40 °C using 25 °C as reference
** 3000 foot-candles generated by 3,400K Tungsten source
CAUTION: Federal (USA) Law restricts this device to sale by or on the order of a physician or licensed practitioner.
WARRANTY
BIOSENSORS warrants all its products free from defect in workmanship and materials under proper use and handling. This warranty is in lieu of all other
warranties, whether expressed or implied, including any warranty of merchantability, suitability or fitness for a particular purpose since handling, storage as well
as factors relating to the patient, his diagnosis, treatment, surgical procedures, and other matters beyond BIOSENSORS' control, directly affect BIOSENSORS'
products and the results obtained from their use. BIOSENSORS shall not be liable for any incidental or consequential loss, damage, or expense directly arising
from the use of its products. BIOSENSORS neither assumes, nor authorizes any other person to assume for it, any other additional liability or responsibility in
connection with its products.
PRODUCT INFORMATION
For further information or assistance relating to the BIOSENSORS products, please contact:
Legal Manufacturer:
BIOSENSORS INTERNATIONAL PTE LTD
36 Jalan Tukang
Singapore 619266, SINGAPORE
Tel: +65 6213 5777
Fax: +65 6213 5737
Email: Sales_CCP@biosensors.com
EU Representative:
BIOSENSORS BV
Arnoudstraat 8,
2182 DZ Hillegom,
The Netherlands
Tel: +31 (25) 2517676
Fax: +31 (25) 2526782
Email: sales-ccp-bv@biosensors.com
0344
Electrical Performance
-25 ºC to +70 ºC Transducer Excitation Voltage
+15 ºC to +40 ºC Transducer Excitation Frequency
10% to 90% non condensing Phase Shift
425 to 850 Torr Transducer Excitation Impedance
Transducer Signal Impedance
Transducer Symmetry
-30 mmHg to +300 mmHg Accuracy
-400 mmHg to +4000 mmHg Sensitivity
Any axis Zero Drift after 5 min warm-up
Temperature Sensitivity Coefficient
Zero Shift due to Temperature
Less than 5 μA Light** Sensitivity at 0 mmHg
5 discharges in 5 minutes at 360J Mechanical Shock
5
English
4 to 8 volts RMS
DC to 5000 Hz
< 5 º
- 5 % to + 5 %
Meets AAMI/ANSI BP22 (1994) standard
< 2 mmHg in 4 hrs
< 0.66 % / ºC*
±10 mm Hg maximum*
< 1 mmHg
Withstands 3 falls from 1 meter
DLCK-0011-003 REV. A2H8
DLCK-0011-003 REV. H8