KCI ABThera, Instructions For Use Manual

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7
KCI Medical Products (UK) Ltd.
Wimborne, Dorset, BH21 7SH
United Kingdom
www.kci-medical.com
Manufactured for:
KCI USA, Inc.
San Antonio Texas, 78219
www.kci1.com
MANUFACTURER INFORMATION
SYMBOLS USED
SPECIFICATIONS*
* Specifications subject to change without notice.
Rx only
Caution:
Federal (USA) law restricts this device to sale by or on the order of a physician.
Do not use if package
is damaged or open
Single Use Only
Biological Risk
Sterilized with radiation
Keep Dry
Not for regular waste
disposal
Conforms with the Medical
Device Directive (93/42/EEC)
and has been subject to the
conformity procedures laid
down in the council directive
ETL Listed, Conforms to UL
Std. 60601-1 certified to
CAN/CSA C22.2 Std. No.
601.1.
Date of
Manufacture
Manufacturer
Authorized Representative
in the European
Community
Use By
Consult
Instructions
for Use
0473
i
STERILE
NON
Refer to Instruction
Manual
Type B applied
part
Non Sterile
US
CM
C
3182664
AC POWER / BATTERY
• ABThera
™
(NPT) Unit should remain plugged into an AC power source while in use or in
storage to keep batteries charged.
• ABThera
™
(NPT)
Unit operates on an auto-ranging AC / DC power supply with a hospital
grade power cord.
• When fully charged the
ABThera ™ (NPT)
Unit will provide battery power in order to
maintain therapy during patient transport. Plug ABThera
™
power cord into an AC power
source immediately after transport to maintain battery charge.
• When unplugged, ABThera
™
(NPT) Unit will switch from AC to battery power without user
intervention or therapy loss.
• Battery will fully recharge in approximately eight hours.
AUTOMATIC SHUTDOWN
While operating on battery power, if battery charge falls below a critical level (approximately
two hours or one hour after low battery alarm sounds) the ABThera
™
(NPT) Unit will
automatically turn off. When plugged into an AC outlet, the ABThera
™
(NPT) Unit will remain
Off until the Power On / Off button is pressed at which time therapy will resume (refer to
Keep Negative Pressure On under WARNINGS ). See also Low Battery Alarm in the
Alarms section.
CARE AND CLEANING
Between patient use and if the product becomes soiled while in use in the hospital or other
healthcare organization, disinfectants containing quaternary ammonium compounds or
other similar disinfectant products may be used to clean the ABThera
™
(NPT) Unit. All visible
organic material should be cleaned from the device prior to disinfection. Use personal
protective equipment (PPE) and hand hygiene protocols in accordance with local protocols
for cleaning and disinfection.
CAUTION: Avoid spilling fluid on any part of the ABThera
™
(NPT) Unit. Fluids remaining
on electronic controls can cause corrosion which can cause the electronic components to
fail. Component failure may cause the ABThera
™
(NPT) Unit to operate erratically, possibly
producing potential hazards to patient or care providers.
Dimensions
11.0 in H x 11.25 in L x 6.0 in D
27.94 cm x 28.6 cm x 15.2 cm
Weight
Therapy Unit only 5.7 lbs / 2.6 kg
Pressure options 100-150 mmHg, 13.3-20 kPa
Canister Volume 1000 cc / mL
Environmental Conditions
Storage Conditions
Temperature Range
-20º F (-29º C) to 140º F (60º C)
Operating Conditions
Temperature Range
50º F (10º C) to 100º F (38º C)
Altitude Range
Optimum Performance 0 to 8,000 ft (0 to 2438 m)
Electrical
Power Supply Input 100 V~ - 240 V~, 50/60 Hz
Power Supply Current 2.5 A max (100 V)
0.9 A (100 V~), 0.4 A (240 V~)
Current Leakage <100 Microamps (115 V)
<300 Microamps (230 V)
Battery Run Life 2 hours (approximately)
Battery Charge Time 8 hours (approximately)
IEC Classification
Medical Equipment
Equipment not suitable for use in presence of
flammable anesthetic mixture with air, oxygen or
nitrous oxide.
Type B Applied Part
IPX1
Power Cord Battery Door