Fluke Biomedical warrants this instrument against defects in materials and workmanship
for one year from the date of original purchase. During the warranty period, we will
repair or at our option replace, at no charge, a product that proves to be defective,
provided you return the product, shipping prepaid, to Fluke Biomedical. This warranty
covers the original purchaser only and is not transferable. The warranty does not apply if
the product has been damaged by accident or misuse or has been serviced or modified by
anyone other than an authorized Fluke Biomedical service facility. NO OTHER
WARRANTIES, SUCH AS FITNESS FOR A PARTICULAR PURPOSE, ARE
EXPRESSED OR IMPLIED. FLUKE SHALL NOT BE LIABLE FOR ANY SPECIAL,
INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOSSES,
INCLUDING LOSS OF DATA, ARISING FROM ANY CAUSE OR THEORY.
This warranty covers only serialized products and their accessory items that bear a
distinct serial number tag. Recalibration of instruments is not covered under the warranty
This warranty gives you specific legal rights and you may also have other rights that vary
in different jurisdictions. Since some jurisdictions do not allow the exclusion or limitation
of an implied warranty or of incidental or consequential damages, this limitation of
liability may not apply to you. If any provision of this warranty is held invalid or
unenforceable by a court or other decision-maker of competent jurisdiction, such holding
will not affect the validity or enforceability of any other provision.
Fluke Biomedical agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in
service training programs and other technical publications. If you would like other reproductions or distributions, submit a written
request to Fluke Biomedical.
Unpacking and Inspection
Follow standard receiving practices upon receipt of the instrument. Check the shipping carton for damage. If damage is found, stop
unpacking the instrument. Notify the carrier and ask for an agent to be present while the instrument is unpacked. There are no special
unpacking instructions, but be careful not to damage the instrument when unpacking it. Inspect the instrument for physical damage such
as bent or broken parts, dents, or scratches.
Technical Support
For application support or answers to technical questions, either email techservices@flukebiomedical.com or call 1-800- 648-7952 or
1-425-446-6945.
Claims
Our routine method of shipment is via common carrier, FOB origin. Upon delivery, if physical damage is found, retain all packing
materials in their original condition and contact the carrier immediately to file a claim. If the instrument is delivered in good physical
condition but does not operate within specifications, or if there are any other problems not caused by shipping damage, please contact
Fluke Biomedical or your local sales representative.
Standard Terms and Conditions
Refunds and Credits
Please note that only serialized products and their accessory items (i.e., products and items bearing a distinct serial number
tag) are eligible for partial refund and/or credit. Nonserialized parts and accessory items (e.g., cables, carrying cases,
auxiliary modules, etc.) are not eligible for return or refund. Only products returned within 90 days from the date of original
purchase are eligible for refund/credit. In order to receive a partial refund/credit of a product purchase price on a serialized product, the
product must not have been damaged by the customer or by the carrier chosen by the customer to return the goods, and the product
must be returned complete (meaning with all manuals, cables, accessories, etc.) and in “as new” and resalable condition. Products not
returned within 90 days of purchase, or products which are not in “as new” and resalable condition, are not eligible for credit return and
will be returned to the customer. The Return Procedure (see below) must be followed to assure prompt refund/credit.
Restocking Charges
Products returned within 30 days of original purchase are subject to a minimum restocking fee of 15 %. Products returned in excess of
30 days after purchase, but prior to 90 days, are subject to a minimum restocking fee of 20 %. Additional charges for damage and/or
missing parts and accessories will be applied to all returns.
Return Procedure
All items being returned (including all warranty-claim shipments) must be sent freight-prepaid to our factory location. When you return
an instrument to Fluke Biomedical, we recommend using United Parcel Service, Federal Express, or Air Parcel Post. We also
recommend that you insure your shipment for its actual replacement cost. Fluke Biomedical will not be responsible for lost shipments
or instruments that are received in damaged condition due to improper packaging or handling.
Use the original carton and packaging material for shipment. If they are not available, we recommend the following guide for
repackaging:
Use a double-walled carton of sufficient strength for the weight being shipped.
Use heavy paper or cardboard to protect all instrument surfaces. Use nonabrasive material around all projecting parts.
Use at least four inches of tightly packed, industry-approved, shock-absorbent material around the instrument.
Returns for partial refund/credit:
Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number, obtained from our
Order Entry Group at 1-800-648-7952 or 1-425-446-6945.
Repair and calibration:
To find the nearest service center, go to www.flukebiomedical.com/service
In the U.S.A.:
Cleveland Calibration Lab
Tel: 1-800-850-4606
Email: globalcal@flukebiomedical.com
In Europe, Middle East, and Africa:
Eindhoven Calibration Lab
Tel: +31-402-675300
Email: ServiceDesk@fluke.com
In Asia:
Everett Calibration Lab
Tel: +425-446-6945
Email: service.international@fluke.com
, or
Certification
This instrument was thoroughly tested and inspected. It was found to meet Fluke Biomedical’s manufacturing specifications when it
was shipped from the factory. Calibration measurements are traceable to the National Institute of Standards and Technology (NIST).
Devices for which there are no NIST calibration standards are measured against in-house performance standards using accepted test
procedures.
WARNING
Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards or
improper operation. Fluke Biomedical will not be responsible for any injuries sustained due to unauthorized equipment
modifications.
Restrictions and Liabilities
Information in this document is subject to change and does not represent a commitment by Fluke Biomedical. Changes made
to the information in this document will be incorporated in new editions of the publication. No responsibility is assumed by
Fluke Biomedical for the use or reliability of software or equipment that is not supplied by Fluke Biomedical, or by its
affiliated dealers.
Manufacturing Location
The CuffLink NIBP Analyzer is manufactured in Everett, Washington by Fluke Biomedical, 6920 Seaway Blvd., Everett,
WA, U.S.A.
Table of Contents
Chapter Title Page
1 Introduction and Specifications......................................................... 1-1
The CuffLink Non-Invasive Blood Pressure Analyzer, hereafter referred to as the
Analyzer, provides accurate and repeatable dynamic blood pressure (BP) waveforms for
evaluation of both semi and fully automated oscillometric non-invasive blood pressure
(NIBP) devices. The Analyzer is shown in Figure 1-1.
To test a device, wrap the BP cuff around the supplied mandrel and insert the cuff adapter
in the pressurized line. All tests are conducted with the BP cuff connected to the system.
The Analyzer can generate BP waveforms for seven adult (oscillometric), five neonate
(oscillometric), and 5 arrhythmias. The different systolic/diastolic pressure gradients
simulate a physiological range of normal, hypotensive, and hypertensive adult or neonate
patients. Actual patient data was used to design the preprogrammed peripheral pulse
waveforms and envelopes.
The Analyzer can produce qualitative measurements of BP cuff pressure and inflate /
deflate timing, as shown in Figure 1-2.
1-3
Cufflink
Operators Manual
CUFF
PRESSURE
TIME
Figure 1-2. Cuff pressure waveform during blood pressure measurement
The Analyzer also offers automated leak testing of NIBP monitors. An internal pump
pressurizes the NIBP system under test. Press a key to initiate a 60 second leak test once
the desired pressure is reached. Use the Analyzer’s digital manometer instead of a
mercury column for doing pressure measurements. The Analyzer facilitates overpressure
testing of NIBP monitors by automatically detecting and displaying the overpressure
point.
• Automated static pressure measurements, leakage testing, and relief-valve testing
• Five automated NIBP testing autosequences
• Five arrhythmia selections
• Adult and neonatal NIBP selections
• Direct interface with medTester 5000C
• Adjustable heart rate values
• Calendar clock with battery backup
• Internal PCB expansion slot
New Features (Firmware Revision 3.0 and Later)
Firmware revision 3.0 included the following additions and updates, including a set of
adult arrhythmias, an internal pump, and additions to pressure testing.
Arrhythmias
The Analyzer features five new arrhythmias to test NIBP monitors in the presence of
typical patient arrhythmias. These clinically derived simulations are representations of
the peripheral pulse, as seen by an oscillometric NIBP monitor.
Each arrhythmia is generated on a random basis throughout the entire pressure curve
cycle. The variations in pulse timing and amplitude are relatively small.
1-4
Introduction and Specifications
New Features (Firmware Revision 3.0 and Later) 1
Premature Atrial Contraction (PAC)
The first pulse of the PAC cycle is premature and lower in amplitude than a normal sinus
pulse. The next pulse would be back in sync with normal sinus and slightly higher in
amplitude. All subsequent pulses are normal.
Premature Ventricular Contraction (PVC)
This is a representation of the peripheral pulse similar to PAC
Atrial Fibrillation (AF)
The AF cycle has an irregular R to R interval. Its occurrence and properties (early vs.
late) are random throughout the pressure curve cycle.
Missed Beat (MB)
A complete beat is randomly skipped during the pressure curve cycle. The following beat
reverts to normal R to R intervals.
Aberrant Sinus Conduction (AS)
The AS cycle inserts one pulse so low that it is virtually non-existent. This causes the
Analyzer to skip one diastolic pulse and then return to normal sinus pulses.
Pressure Testing
The Analyzer now has the following enhancements to its pressure testing capability.
Internal Pump
The Analyzer now has an internal compressor which eliminates the need to manually
inflate the cuff for NIBP monitor testing. This automates static pressure measurements,
leak testing, and relief valve testing.
Pop Off Added to Press Menu
Perform over-pressure tests on NIBP monitors with this addition to the PRESS menu.
Utility Menu Added to Leak Test
Select cuff size, turn printing on or off, and choose a target pressure for leak testing.
Manometer
The Analyzer simulates a digital manometer with pump capabilities.
1-5
Cufflink
Operators Manual
Remote Commands
Table 1-1 lists new CuffLink RS232 commands to support new functions.
Table 1-1. New RS232 Remote Commands
Command Function
DEFLATE Releases pressure inside CuffLink
INFLATE Pumps CuffLink to 200 mmHg or specified pressure
PUMPPCB Determines if pump PCB is installed in CuffLink
General Safety Considerations
Read the Users Manual before operating the Analyzer.
Symbols
Table 1-2 describes the symbols associated with the Analyzer.
Table 1-2. Symbols
Symbol Description
X Hazardous voltage
W Important information; refer to manual.
Œ
P Conforms to European Union directives
~
Hg Contains mercury. Dispose properly.
Conforms to UL Std 3101-1; certified to CAN/USA Std C22.2 No.
1010.1
Do not dispose of this product as unsorted municipal waste. Go
to Fluke’s website for recycling information.
1-6
Introduction and Specifications
General Safety Considerations 1
Warnings and Cautions
A Warning identifies hazardous conditions and actions that could cause bodily harm or
death.
A Caution identifies conditions and actions that could damage the Analyzer, the
equipment under test, or cause permanent loss of data.
XW Warning
To avoid possible electrical shock or personal injury, follow
these guidelines:
• Use this Analyzer only in the manner specified by the
manufacturer.
• Do not use the product if it operates abnormally.
• Do not connect the Analyzer to a patient or equipment
connected to a patient. The Analyzer is intended for
equipment evaluation only and should never be used in
diagnostics, treatment or in any other capacity where the
Analyzer would come in contact with a patient.
• Do not use the product in wet locations, around explosive
gases or dust.
• Never open the Analyzer's case. Dangerous voltages are
present. There are no user replaceable parts in the
Analyzer.
• Have the Analyzer serviced only by qualified personnel.
• The Analyzer must be properly earthed. Only use a supply
socket that has a protective earth contact. If there is any
doubt as to the effectiveness of the supply socket earth, do
not connect the Analyzer.
• Do not use a two-conductor adapter or extension cord; this
will break the protective ground connection.
W Caution
To avoid damage to the Analyzer or adverse affects on its performance, follow these guidelines:
• Do not expose the system to temperature extremes. Ambient
temperatures should remain between 0 °C and 50 °C. System
performance may be adversely affected if temperatures fluctuate
above or below this range.
• Clean the Analyzer only by wiping it down with a clean, lint-free
cloth dampened with a mild detergent solution. Do not spray
liquid directly on or immerse the unit.
1-7
Cufflink
Operators Manual
Instrument Familiarity
Figure 1-3 shows the top and front panel controls and indicators of the Analyzer.
Table 1-3 lists these components with accompanying descriptions. Figure 1-4 shows the
rear panel controls and indicators, and Table 1-4 lists and describes these components.
1
CuffLink
NON-INVASIVE BLOOD PRESSURE ANA
L
YZE
R
2
ESC
F1
F2
F3
F4
F5
BEEPER
V
OLUM
ENT
11
DISPL
E
AY
VIEW
Max
Da
r
k
10
CUFF
CONNECT
CUFF
OUTPUTS
mmHg
PULSE
mHg
DC
3
mmHg
4
5
6
7
8
9
Figure 1-3. Analyzer Top and Front Panel Controls and Indicators
Table 1-3. Analyzer Top and Front Panel Controls and Indicators
Label Component Description
A Display The LCD (Liquid Crystal Display) is a full alphanumeric and
graphic display. The maximum number of characters able
to be on a single line at any given time is 40, and the
number of lines from top to bottom is 8, thereby producing a
possible 320 character display. The graphics mode of the
display is defined by a grid of 64 vertical pixels by 240
horizontal pixels. This mode enables display of the cuff
pressure waveform.
fcv003.eps
1-8
Display viewing angle is adjustable, so if the display appears
blank (view angle set too low), or dark (view angle set too
high) the view angle may need to be adjusted for optimum
visibility (see Display View Control Knob).
Introduction and Specifications
Table 1-3. Analyzer Top and Front Panel Controls and Indicators (cont.)
Label Component Description
Instrument Familiarity 1
B Esc Key The Esc (escape) key enables the user to exit any menu,
exit without saving new data, or abort any function of
CuffLink. Continuously holding down the Esc key will return
the user to the CuffLink logo display from any menu.
C Function Keys The function keys are labeled Fl through F5. Pressing any
one of these keys will execute the function, defined by
software, that is displayed above that particular key.
D Cuff Connect A quick disconnect type of port provides the output
connection from the pulse producing motor inside Cufflink,
to the line connecting the cuff and the BP patient monitor.
E Cuff Output This is a voltage output proportional to cuff pressure
(10mv/mmHg). It is always active with a range of -5 V dc to
+5 V dc (-500 mmHg to +500 mmHg). The accuracy is
specified for positive pressures only.
Example:
1.0 V = 100 mmHg
2.5 V = 250 mmHg
This signal is also useful when connected to a storage
oscilloscope or strip recorder to observe the cuff
inflate/deflate cycle.
Output impedance is 100 Ω.
F Pulse output This is a voltage output proportional to pulse pressure. It is
only active when Cufflink is outputting pressure pulses. The
output is at 0 V in the inactive state. The pulse voltage is
taken from the pressure transducer and the large static cuff
pressure is subtracted. For example, if the cuff is inflated to
150 mmHg and the pulse is 1.2 mmHg in amplitude, only the
1.2 mmHg portion of the signal is presented at this output.
The pulse output voltage is 1 V dc/mmHg and has a range
of -5 VDC to +5 VDC (-5 mmHg to +5 mmHg).
Example:
1.0 V = 1.0 mmHg pulse
0.5 V = 0.5 mmHg pulse
When Cufflink is simulating blood pressure it removes the
static cuff pressure from the pulse output (forcing it to 0
VDC) at the beginning of each heartbeat. During the
heartbeat the amplitude of the pulse is output. As the cuff
deflates (or inflates) this process is repeated for each
heartbeat.
Output impedance is 100 Ω.
1-9
Cufflink
Operators Manual
Table 1-3. Analyzer Top and Front Panel Controls and Indicators (cont.)
Label Component Description
G Sync Output This is a logic level (0 to 5VDC) that outputs a pulse at the
start of every heartbeat. When CuffLink is not outputting
pressure pulses this output is at OVDC. When CuffLink is
outputting pressure pulses the output is high (5VDC) during
the pulse and low between the end of one pulse and the
start of the next pulse. This output is useful for measuring
heart rate and synchronizing a scope trigger for viewing
individual pressure pulses on the pulse output.
Output impedance is 100 Ω.
H Beeper Volume Control Knob The amplitude of the CuffLink audible feedback may be
adjusted by turning the beeper volume control knob. Turning
the knob clockwise (towards the MAX label next to the knob)
will increase the volume of the beeper, while turning the
knob counterclockwise will decrease the beeper volume.
I Display View Control Knob The angle at which the display is most visible is adjustable
with the display view control knob. Turning the knob
clockwise (towards the DARK label next to the knob) will
increase the contrast of the display, or make the display
darker. Turning the knob counterclockwise will decrease the
contrast, making the display lighter.
J Ent Key Pressing the Ent (enter) key will select a highlighted menu,
initiate a CuffLink function, or store data in EEROM. In
effect, the enter key is the opposite of the Esc key.
K Arrow keys The arrow keys are the cursor control keys. Pressing the up
arrow key moves the cursor on the display in a upward
direction or increases the highlighted value. Pressing the
down arrow key moves the cursor on the display in a
downward direction or decreases the highlighted value. The
down arrow key is also capable of pulling down the
submenus of a highlighted main menu. Pressing the left or
right arrow keys will produce cursor movement in the
corresponding direction. Holding any arrow key down
continuously will cause a repeating of the action of that key.
L Handle The handle for transporting CuffLink is located on the right
A Power Cord Input The input for the Cufflink power cord is located next to the
power switch. This is the connection for the detachable
power cord.
B Power Switch The on position of the power switch is represented by 1 and
the off position is labeled 0.
C Fuse Cover The fuse(s) are located behind the fuse cover. The fuse
cover may be carefully pried open at 3a.
D Voltage Selector CuffLink is able to operate on two different line voltages.
The voltage selector indicates the voltage (either 120V or
240V) at which CuffLink will operate. There are an
additional two voltages (100V and 220V) listed on the back
panel. These do not apply to CuffLink.
E Fan Intake A hole cut in the rear panel of the case provides ventilation
for Cufflink from the fan. Care should be exercised not to
block the fan intake or to insert anything into the metal
protector.
F RS232 Port This is the connector for the RS-232 serial interface. It
is a 25 pin (DB25), male, D shell connector (same
pinout as PC compatible computer).
G Printer Port The connector for the parallel printer is a 25 pin
(DB25), female, D shell connector. The printer port is
Centronics compatible (same pinout as a PC
compatible computer).
1-11
Cufflink
Operators Manual
Table 1-4. Rear Panel Controls and Indicators
Label Component Description
H Serial Port The four digit Cufflink serial number is located above
the printer port. The serial number should be
documented along with the model number whenever
Cufflink is shipped to Dynatech Nevada.
I Fuse Label The fuse label documents the type of fuses needed.
Use one 1ASB 250 V ac fuse (DNI part no. 1005-
0184) if Cufflink is set for 120 V operation, and two
1/2 A 250 V ac fuses (DNI part no. 1005-0185) if
Cufflink is set for 240 V operation.
Replacing Fuses
1. Turn Cufflink's power off and unplug the power cord.
2. Remove the fuse cover with a small blade screwdriver.
The plastic fuse holder should pop out of the Cufflink
case.
3. Use the screwdriver to pry the old fuse out of the plastic
holder.
4. Install the new fuse.
5. Replace the fuse holder by simply pushing the fuse
holder back into place.
Specifications
The following are general and electrical specifications for the Analyzer.