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Revision #: 6
Engr. Unit of Marginal Ideal
Importance Source Specification (description) Comments/Status
Spec. # Measure Value Value
CN1, CN15,
ES1 1 Heart Pressurized mm Hg +/- 10 80 blood pressure at rest
CN17
aorta/left ventrical relative to
ES2 1 CN2, CN15 Realistic Orientation of Heart degrees +/- 5 75 head of torso (which is
considered 90 degrees)
is it near the organs it should
ES2.1 1 CN2, CN15 Position in Relation to Other Organs yes/no N/A yes
be? - yes is achieved by
22.86 x inspection
ES3 1 CN3, CN26 Surgical Field cm x cm +/- 2.54 in relation to surgeon visibility
25.4
CN3,CN4,
22.86 x
ES3.1 1 CN15, Confined workspace cm x cm +/- 2.54
25.4
CN26
CN5, CN7, surgeons purchase hearts
ES4 1 Feature: Calf Heart yes/no N/A yes
CN14 independently
CN6, CN13, can it be cleaned with cleaning
ES5 1 Feature: Cleanable Materials Used yes/no N/A yes
CN18 supplies?
prep for the trainer to be used
ES6 2 CN13 Quick setup minutes +/-15 30
once
ES6.1 2 CN13 Between uses prep time minutes +/-5 16 prep per heart
this is estimated teardown for
ES6.2 2 CN13 Quick teardown minutes +/-15 60
one trainer, not multiple
quantity of
ES6.3 2 CN13 One power cord -1 1
power cords
quantity of
ES6.4 2 CN13 One Power Switch -1 1
switches
CN6,CN13, Wipe down parts that touch
ES7 4 Maintenance
CN18 the heart between use.
CN6, CN13, Featured for Contained Mess -
ES7.1 4 yes/no N/A yes
CN18 Single Drain Point
Yes is achieved when tubing is
Feature: Replaceable Connected made out of parts that a
ES8 1 CN8 yes/no N/A yes
Tubing to Heart surgeon can easily purchase
and therefore replace.
ES8.1 1 CN8, CN15 Size of tubing to Aorta cm 2.54
-1.27
Yes is achieved if the trainer
survives standard usage for
CN11, given amount of time without
ES9 2 3-4 times/month yes/no N/A yes
CN22 breaking or only requiring
standard tools to fix (no
special tools).
CN14,
CN16,
CN20,
Replaceable NonHeart Organs made
ES10 2 CN21, $ +/-25 50 potentially plasticize
of inexpensive materials
CN25,
CN28,
CN29
ES11 2 CN15 Match Average Patient Average Male
CN15,
ES11.1 2 Heart Beat Rate beats/minute +10 / -0 40
CN17
CN12,
ES11.2 2 CN15, Thoracic Cavity Volume cm3 +/- 60 4060.1 value without lungs
CN24
CN12,
ES11.3 7 CN15, Body Surface Area m2 +/- 0.15 2
CN24
CN14,
CN15, Feature: Incorporation of lungs (fake -
ES12 3 yes/no N/A yes
CN16, polymer/elastomer)
CN28
LVAD Is Allowed to Pump
CN15,
After Implantation (this
CN17,
currently isn't mandatory). If
ES13 5 CN19, Blood flow ml/heart beat +/- 10 ml 70
this is achieved, mistakes can
CN23,
be detected when pump
CN30
doesn't work properly
CN15,
CN17,
ES13.1 5 CN19, Amount of blood Liters +/- 0.4 5.6 average person
CN23,
CN30
ES14 5 CN22 Trainer Life years +/- 2 7
ES15 8 CN4, CN26 Rib Spreading Length cm +/- 1 22.86
Engr. Spec. #: enables cross-referencing (traceability) and allows mapping to lower level specs within separate documents
Source: Customer need #, regulatory standard (eg. EN 60601), and/or "implied" (must exist but doesn't have an associated customer need)
Description: quantitative, measureable, testable details
*This table can be expanded to document test results
This represents the general spec title
This represents that further research is required
Anything written in
Spec Met? Proof Reference Documents read means I'm not
sure about it
Pressure sensor shows that the
pump can provide the desired FluidsSystemTest_wRe
Yes
pressure at the point of tubing near sults.doc
the heart.
Tubing placement to the heart
Yes
allows for proper orientation
located near the lungs above the
Yes anatomy books
diaphragm
When ribs are open, the visible
Yes
amount of area meets these specs
surgeons may use a calf heart in
Yes
our system
aluminum frame, silicone skin and
Yes lung coating, and plastic
diaphragm/abdominal pocket (all
cleanable materials)
Haven't tested the quick connect
stuff for this
Haven't tested the quick connect
stuff for this
Needs to be tested, but I think
we've achieved this
The surgeons only need to
interface with 1 power chord which
Yes
is coming out of the iso
transformer
The surgeons must turn on both
No
the isotransformer and the laptop
Yes drain pan and waste reservoir
May not actually be easy to replace
Yes though, although that may not
mean anything
test what occurs with a
Yes 1/2 inch tubing is used
1 inch diameter aorta
Unsure how to test
this. I want to say
that we can't
guarentee this
painters drop cloth, packaging
balloons for the abdominal pocket,
Mostly and lungs that may be reproducible lung solid works model
(cost may be time more than
anything)
Customer gave permission to not
No pursue these specifications during
the first generation of this project
assembly
designed and measured with these
Yes documentations of
dimensions
frame/tray
assembly
designed and measured with these
Yes documentations of
dimensions
frame/tray
fake lung is coated with silicone
Yes
rubber
FluidsSystemTest_wRe
Yes flow rate was measured and tested
sults.doc
Our fluid reservoir can only hold 4
No BOM
liters of fluid
Unsure how to test
this. I want to say
that we can't
guarentee this
designed and measured with these assembly
Yes
dimensions documentations of
