Terumo 801763, Operator'S Manual, Page: 16 / 359

1-5
About Advanced Perfusion System 1
System Equipment Precautions
Grounding reliability can only be achieved when this equipment is connected to an
appropriate receptacle which has been inspected for proper grounding.
This device requires a dedicated 20 Amp AC (Mains) power source for the 100V –
120V model or a dedicated 10 Amp AC (Mains) power source for the 220V – 240V
model.
Complete any external equipment connections before turning the system on as
connecting equipment during use may cause system malfunction.
Do not use this device in the presence of explosive or flammable gases.
To avoid electrical shock hazard, do not remove panels; refer servicing to qualified
service personnel.
Do not operate the system without the module covers secured in place as spilled
liquids may damage the connections.
Connect only hospital equipment of appropriate voltage and current rating to the
auxiliary outlet.
The auxiliary outlet is not backed up by battery power. During loss of AC (Mains)
power any equipment connected to the auxiliary outlet will lose power and remain
unpowered until AC (Mains) power is restored.
Do not use extension cords to connect the system to AC (Mains) power nor to
connect modules or accessories to the system. Use of extension cords may
compromise performance.
In the event that an AC (Mains) circuit breaker trips immediately after a reset, DO
NOT attempt to reset again. The system will only operate from battery power until it
has been repaired. Call for service.
Use only the cables provided to connect pumps and flowmeter modules to the
system.
The use of accessory equipment not complying with the equivalent safety
requirements of this system may lead to a reduced level of safety of the resulting
system. Consideration relating to the choice shall include:
•
use of the accessory in the patient vicinity;
• evidence that safety certification of the accessory has been performed in
accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized
international standards.
Equipment used to heat and cool the water used to regulate the temperature of the
blood supplied to a heat exchanger should be rated Type CF. If the equipment is not
Type CF and a malfunction occurs, the possibility exists that electrical current may
pass through the heat exchanger and into the patient perfusion circuit.
The system can be stored in a ventilated area with a temperature range of 0°C to
40°C (32°F to 104°F) and a relative humidity range of 10% to 95%, non-condensing.
The system can be operated at a temperature range of 10°C to 40°C (50°F to 104°F)
at 30% to 75% relative humidity, non-condensing.