I Introduction; Important Information; Warnings - Smiths Medical Medfusion 3000 Series Technical & Service Manual

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Important Information

WARNING: Read this entire manual before attempt-
ing and service or repair on a Medfusion™ 3000 Se-
ries Syringe Infusion Pump. Failure to follow the
instructions and important information contained
in this manual, or improper/inadequate testing,
service, repair or troubleshooting can lead to death
or serious injury. Warnings, cautions and other im-
portant safety information can be found in this sec-
tion, and throughout the manual (they are contained
within lines at top and bottom).
The term WARNING is used to indicate a hazard that
has the potential to cause injury or death to a tech-
nician, patient or user. The term CAUTION is used
to indicate a hazard that has the potential to cause
damage to the product or other property.
Note: This manual supersedes all previous revisions.

Warnings

• Attempts to repair or maintain a pump by person-
nel without proper qualifications or training may
create a major hazard which could result in serious
injury or death to the patient or the user.
• Use only approved parts and procedures for repair
and maintenance of this pump. Failure to follow
this manual may create a major hazard which
could result in serious injury or death to the pa-
tient or the user.
• Repair Pump in ESD Controlled Work Area:
The pump case should only be opened at a work-
station with Electrostatic controls, including a
grounded mat and wrist-strap.
• Pump Maintenance: Only trained biomedical
service personnel may service this pump. Service
personnel should disconnect the AC power cord
before servicing the pump.
• AC Power: The only means of removing AC
power is to disconnect the AC power cord. While
the AC power cord is attached to the pump and
plugged into an AC outlet, live mains voltage is
present within the pump.
• Manufacturer Recommended Maintenance:
Always maintain this pump following manufac-
turer recommended instructions in this Service
Manual. An improperly maintained pump may
cause serious injury to a patient or user.
• Safety Class II, Type CF Medical Equipment: The
40-5648-51B
pump is listed as Safety Class II, Type CF equip-
ment. Protection against electrical shock does not
rely only upon basic insulation, but instead relies
on double or reinforced insulation. As such, this
equipment does not utilize a third wire ground
(earth ground). Therefore, when doing line leak-
age test it is not necessary to measure leakage in
both the open ground and closed ground setting.
Nor is it necessary to perform a ground resistance
test.
• Safety Class II with functional earth, Type CF
Medical Equipment: The pump is listed as Safety
Class II with functional earth, Type CF equip-
ment. Protection against electrical shock does not
rely only upon basic insulation, but instead relies
on double or reinforced insulation. As such, this
equipment utilizes a third wire ground (earth
ground) lead of the power cord as earth return for
electromagnetic energy and does not serve as a
safety function. Therefore it is neither possible nor
necessary to perform a ground resistance test.
• Battery Replacement: Observe ESD handling
precautions when replacing the battery. Replace
battery only with same Smiths Medical part/model
number. Recycle batteries in compliance with ap-
plicable local regulations.
• Collect Separately. There are potential health haz-
ards associated with improper disposal of batter-
ies, electronics, and contaminated (used) infusion
sets and syringes. Dispose of used batteries, infu-
sion sets, syringes, and other used accessories, or a
pump that has reached the end of its useful life, in
an environmentally safe manner, and according to
any regulations that may apply.
• Clean the Pump: Always clean the pump thor-
oughly before performing maintenance on it. This
is recommended by the United States Occupa-
tional Safety & Health Administration (OSHA) as
a protection from potential biohazard.
• External DC Power: Any power source connected
to the external DC jack must be IEC 60601-1 cer-
tified for medical equipment: Type CF, Safety Class
II. Connecting external power to the pump creates
a medical system; therefore, the user is responsible
for compliance with IEC 60601-1 standards. Refer
all questions to Smiths Medical Technical Service
department.
Introduction
1

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Medfusion 3500bc

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