Braun Perfusor Space Instructions For Use Manual page 8

Enteral Nutrition
The Perfusor® Space may be used for enteral nutrition. Do not use enteral fluids
for intravenous infusion as this may harm your patient. For this reason only use
disposables dedicated and labeled for enteral nutrition.
Other components
• Use only pressure proof and compatible disposable items (min. 2 bar/
• Where several infusion lines are connected on one single vascular access, the
• Refer to the according manufacturer's information for possible
• Use only compatible combinations of equipment, accessories, working parts
• The use of incompatible disposables may influence the technical
• Connected electrical equipment must comply with the relevant IEC/EN-
Safety Standards
Perfusor® Space satisfies all safety standards for medical electrical devices in
compliance with IEC/EN 60601-1 and IEC/EN 60601-2-24.
• The EMC-limits (electro-magnetic compatibility) according to
• The Perfusor® Space fulfils the applicable requirements of EN 13718 to be
Safety Instructions for using PCA
• In case the demand button is used with SpaceStation the PCA pump has to
8
1500 mm Hg) to avoid influencing performance data - which would result in
impairing patient safety.
possibility of the lines exerting a mutual influence over each other cannot be
excluded.
incompatibilities of equipment with respect to drugs.
and disposables with luer lock connectors.
specifications of the device.
specifications (e.g. IEC/EN 60950 for data-processing equipment).
The user/operator is responsible for the system configuration if additional
equipment is connected. The international standard IEC/EN 60601-1-1 has to
be taken into account.
IEC 60601-1-2:2007 and IEC 60601-2-24: 2012 are maintained. If the
equipment is operated in the vicinity of other equipment which may cause
high levels of interference (e.g. HF surgical equipment, nuclear spin
tomography units, mobile telephones etc.) may be disturbed. Maintain the
protective distancesrecommended by the manufacturers of these devices.
used in the air, on the water and in difficult terrain. During transport the
Perfusor® Space needs to be fixed on a suitable restraint system by means of
SpaceStation or Pole Clamp SP. When stored under temperature conditions
beyond the defined operating conditions the Perfusor® Space needs to
remain under room temperature at least one hour before usage.
be placed in the lowest slot of the lowest SpaceStation.
PATIENT SAFETY