Document # 49044IM1
Revision 7.5 2
Dated February 16, 2017
Manufacturer: Chrono-log Corp.
2 West Park Road
Havertown, PA 19083
USA
Phone: 1-610-853-1130
Email: chronolog@chronolog.com
EC Rep: BioTop Medical
Poortgebouw Noord,
Rijnsburgerweg 10
2333 AA Leiden
Netherlands
Phone 31 71 528 01 12
Fax 31 71 528 01 15
Power requirements: 115 or 230VAC; 50 or 60 Hz 60 watts max.
The main supply voltage fluctuations are
not to exceed 10% of the nominal supply
voltage.
Fuse: For 115 VAC: 630 mA, 250V; Time lag,
5x20mm or equivalent;
For 230 VAC: 315 mA, 250V; Time Lag,
5x20mm or equivalent.
Warnings:
WARNING- FIRE HAZARD For continued protection replace only
with the same type and rating of fuse.
Caution – This Instrument is intended for indoor use only. Failure
to operate in a protected environment in accordance with
instructions may present a shock hazard.
Warning: Patient specimens should be handled as if they contain
infectious materials, in accordance with national guidelines for
Biosafety/Hazard Group 2. In the United States, the universal
precautions recommended by the Department of Labor,
Occupational Safety and Health Administration apply.
(Occupational Exposure to Blood Borne Pathogens; final rule (29
CFR 1910, 1030) FEDERAL REGISTER.
This device complies with part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) This device may not
cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause
undesired operation.
NOTE: This equipment has been tested and found to comply with
the limits for a Class B digital device, pursuant to part 15 of the
FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that
interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference
by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and
receiver.
• Connect the equipment into an outlet on a circuit different
from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for
help.
Caution: Federal law restricts this device to sale by or on the order
of a physician for measuring platelet aggregation in platelet rich
plasma.
VENTILATION
To ensure that the system has adequate ventilation, please
adhere to the following instructions carefully:
1. Do not place Aggregometer within a closed in wall or on top
of cloth material which can act as insulation.
2. Do not place Aggregometer where it will receive direct
sunlight.
3. Do not place Aggregometer next to a heat source of any kind
including heating vents.
4. Make sure that all openings on the Aggregometer remain
unobstructed, especially the fan guard on the back of the
unit.
HAZARDS
There are no hazards associated specifically with use of the
Aggregometer.
However, normal precautions, which apply to the handling of
blood, should be observed in handling the samples.
Non-factory authorized service personnel should not remove the
instrument cover.
MISUSE
To prevent electrical shock, the Aggregometer and peripheral
power cables must be plugged into a properly grounded power
source. Do not use adaptor plugs or remove grounding prong
from cable. If an extension cable must be used, use a three wire
cable with properly grounded plugs.
Do not spill liquids or food on your Aggregometer.
Do not put objects or materials other than cuvettes in the heater
block wells.
Do not push any object through the fan guard.
SUMMARY AND EXPLANATION
When a blood vessel is damaged, platelets adhere to the wound
edges, aggregate, synthesize prostaglandins and release
serotonin, ADP and ATP.
8
Prostaglandin synthesis and release
products cause further aggregation. The coagulation cascade is
initiated, thrombin generated, fibrin formed and the platelet plug
anchored to the damaged vessel.
15
Defects in platelet function due to lack of a cell membrane
glycoprotein, cytoplasmic storage granules, platelet enzymes or a
plasma factor often result in excessive bleeding after trauma,
frequent bruising or nosebleeds, or excessive menstrual blood
loss. Yet patients who present with one or more of these clinical
signs are much more likely to be tested initially for coagulation
abnormalities than for platelet dysfunction. Further, surgical
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