FORCE GAUGE CALIBRATION
If the zero reading of the force gauge (Figure 16) has drifted away from the zero line, the gauge
should be readjusted prior to further use as follows:
1. Remove the suction cup by pulling it from the stem of the handle.
2. Use a Phillips screwdriver to loosen the screw at the top of the connection stem (Figure 17)
with a firm turn. Remove the nylon stem and washer located inside the stem (Figure 18).
3. Insert a straight blade screwdriver (4 mm [1/8“] wide) in threaded hole at the end of the
spring/plunger assembly and catch the slot of the adjustment screw seated about 3 cm (1”)
down inside the brass plunger (Figure 18).
4. Loosen the screw. If there is excessive resistance, heat the screw slightly using a hairdryer to
soften the locking resin (Figure 19).
5. Loosen the screw and adjust it until the gauge is on the zero line (Figure 16). Compress the
spring a few times and check that the zero reading remains correct. Fine readjustment may
be needed. If the screw was heated, wait until it cools to room temperature before proceeding
to the next step.
6. Lock the screw by applying a drop of LOCTITE 242 locking fluid (or equivalent) to top edge
of screw. Use a toothpick to ensure that the fluid is applied directly to the entire top edge of
the screw. Wait ten minutes for the locking fluid to set.
7. Reassemble in reverse order. Place the washer into the nylon stem as shown in Figure 20.
Apply a drop of locking fluid to the tip of the thread near the end of the screw. Push the screw
up though the end of the stem and through the washer.
8. Finally, slip the spring/plunger on the handle down into the stem. Rotate the stem until the slot
in the stem aligns with the rib in the handle and slips all the way into the handle, then tighten
the screw.
9. Wait 24 hours before using the device to ensure that the locking resin obtains full strength.
During this time, the ResQPUMP should be hung by the strap or left resting on the handle
with the suction cup pointing up.
Figure 16
Figure 17
Figure 18
Figure 19
Figure 20
Decompression
Compression
30
0
kg
40
15
10
50
80/min
LIFT
to 10 kgs
Use enough
force to
COMPRESS
to 2” (5 cm) depth
SUMMARY OF PRIMARY CLINICAL STUDY
Study Design and Methods
The ResQTRIAL was a prospective, multi-center, two-arm, randomized, controlled,
partially masked clinical study conducted under 21 C.F.R. §50.24,
Exemption from
Informed Consent under Emergency Circumstances, and was funded by a grant from the
National Institutes of Health (NIH). Study oversight was conducted by an independent Clinical
Events Committee responsible for the review of all adverse events and inclusion/
exclusion adjudication and an independent Data Safety Monitoring Board to review
aggregate data to provide recommendations whether or not to continue subject
enrollment.
Rescuers provided CPR using the ResQCPR System at 80 compressions per minute (the S-CPR
group received compressions at the AHA-recommended rate of 100 compressions per minute).
Patients were followed for one year after cardiac arrest to determine if the ResQCPR System
improved survival rates after cardiac arrest. Neurological outcomes were assessed at the time of
hospital discharge, and then 30, 90 and 365 days after cardiac arrest.
The principal data elements that led to device approval were a post hoc analysis of
survival up to one year after cardiac arrest not incorporating the consideration of
neurological function. The primary safety and effectiveness endpoint defined in the
protocol was survival to hospital discharge with favorable neurologic function, defined as
a modified Rankin Scale score (MRS) of
≤
3. The MRS assessment takes into consideration the
subject’s neurologic status both prior to and following cardiac arrest. However,
conclusions and inferences regarding the original prospective primary endpoint for the ResQTRIAL
(i.e., survival with good neurological outcome) cannot be drawn from the ResQTRIAL due to
interpretability issues related to the neurological component of that composite endpoint. The
hypothesis-based secondary safety endpoint was the overall rate of major adverse events through
hospital discharge. The hypothesis-based secondary effectiveness endpoint was long term
neurologic function assessed using the Cognitive Abilities Screening Instrument (CASI, Version
E-1.1) score at 90 and 365 days. CASI is measured on a scale of 0-100, with higher scores
signifying better outcomes.
All subjects in non-traumatic arrest determined by emergency medical services (EMS)
personnel to require CPR according to their local protocols were randomized and treated
in this study. The intention-to-treat (ITT) population was comprised of all subjects randomized to
S-CPR or CPR using the ResQCPR System who met the study enrollment criteria regardless of
the cause of the non-traumatic cardiac arrest. A subset of the ResQTRIAL ITT population was
comprised of patients who had a cardiac arrest of presumed cardiac etiology and who have the
potential to benefit from CPR. This subgroup was defined as the modified intention-to-treat (mITT)
primary analysis population. Baseline demographics and parameters were similar between study
groups as shown in Table 1.
Table1: ResQTRIAL Pivotal Phase Demographics and Baseline Characteristics
1
Parameter
S-CPR
ResQCPR
ITT
(n=1201)
mITT
(n=813)
ITT
(n=1269)
mITT
(n=842)
Age, years (mean ± SD)
64.2 ± 17.2
66.8 ± 14.5
63.3 ± 17.8
67.0 ± 15.2
Male
752 (62.6)
539 (66.3)
803 (63.3)
559 (66.4)
Race:
White
Asian
Native Hawaiian/Pacific Islander
American Indian/Alaska Native
Black/African American
Unknown
960 (79.9)
39 (3.2)
4 (0.3)
18 (1.5)
152 (12.7)
28 (2.3)
660 (81.2)
31 (3.8)
3 (0.4)
9 (1.1)
94 (11.6)
16 (2.0)
1035 (81.6)
29 (2.3)
1 (0.1)
22 (1.7)
155 (12.2)
26 (2.1)
715 (84.9)
19 (2.3)
1 (0.1)
10 (1.2)
88 (10.5)
9 (1.1)
Ethnicity:
Hispanic/Latino
Not Hispanic/Latino
Unknown
22 (1.8)
1149 (95.7)
30 (2.5)
15 (1.8)
782 (96.2)
16 (2.0)
32 (2.5)
1207 (95.2)
29 (2.3)
19 (2.3)
811 (96.3)
12 (1.4)
Bystander witnessed arrest
EMS witnessed arrest
Unwitnessed arrest
Not available
517 (43.1)
146 (12.2)
536 (44.7)
2
383 (47.1)
76 (9.4)
353 (43.4)
1
546 (43.2)
144 (11.4)
575 (45.5)
4
400 (47.5)
80 (9.5)
361 (42.9)
1
Bystander CPR
Not available
489 (40.7)
1
350 (43.1)
1 (0.1)
532 (42.0)
2
358 (42.5)
0 (0.0)
Initial recorded cardiac rhythm:
Ventricular fibrillation/pulseless
ventricular tachycardia
Asystole
Pulseless electrical activity
Not available
294 (24.5)
597 (49.7)
293 (24.4)
17
247 (30.4)
379 (46.6)
180 (22.1)
7 (0.9)
335 (26.4)
633 (49.9)
284 (22.4)
16
292 (34.7)
376 (44.7)
171 (20.3)
3 (0.4)
911 call to EMS CPR start,
minutes
2
(mean ± SD)
6.7 ± 3.5
6.6 ± 3.4
6.7 ± 3.2
6.7 ± 3.2
911-to-first study device placed,
minutes (mean ± SD)
2
-
-
7.1 ± 3.5
7.1 ± 3.5
Duration CPR, minutes (mean ± SD)
25.6 ± 13.0
27.60 ± 12.24
26.3 ± 12.3
28.10 ± 11.45
Pre-hospital ROSC
3
490 (40.8)
324 (39.9)
524 (41.3)
345 (41.0)
1
Numbers shown are subjects (%) unless otherwise indicated
2
Does not include subjects with EMS witnessed arrests
3
ROSC = Return of spontaneous circulation
Safety and Effectiveness Results
Survival
One of the major objectives of the ResQTRIAL was to determine the safety and effectiveness of the
ResQCPR treatment from the time of a return of spontaneous circulation (ROSC) to survival status
one year later; this is shown in Table 2. The results demonstrated that the likelihood of short and
longer-term survival was improved in the ResQCPR arm. At one year, there was a 34% increase
in the survival rate in subjects in the ITT population receiving CPR with the ResQCPR System
compared with S-CPR.
Table 2: Survival of Out-of-Hospital Cardiac Arrest Subjects Subjects from
ROSC to One Year
1
ITT
mITT
S-CPR
(n=1201)
ResQCPR
(n=1269)
S-CPR
(n=813)
ResQCPR
(n=842)
ROSC during CPR before hospital
admission
490 (40.8)
524 (41.3)
324 (39.9)
345 (41.0)
Admitted to hospital
342 (28.5)
381 (30.0)
216 (26.6)
239 (28.4)
Survived to 24 hours
following arrest
Not available
277 (23.3)
12
310 (24.6)
11
176 (21.6)
9
199 (23.8)
6
Alive at hospital discharge
Not alive at hospital discharge
Not available
123 (10.3)
1072
6
150 (11.9)
1114
5
80 (9.9)
727
6
105 (12.5)
735
2
Alive at 30 days
Not alive at 30 days
Not available
98 (8.3)
1086
17
131 (10.4)
1123
15
65 (8.1)
738
10
96 (11.5)
741
5
Alive at 90 days
Not alive at 90 days
Not available
88 (7.5)
1089
24
116 (9.3)
1129
24
58 (7.3)
740
15
87 (10.4)
746
9
Alive at 1 year
Not alive at 1 year
Not available
68 (5.8)
1103
30
96 (7.8)
1137
36
48 (6.0)
746
19
74 (9.0)
748
20
1
Numbers shown are subjects (%) unless otherwise indicated.
Kaplan Meier survival analyses were performed in the subgroup of subjects who had a return
of spontaneous circulation (ROSC) for both the ITT and mITT populations (where the number of
subjects with ROSC is shown above in Table 1). The findings in these analyses are consistent with
the overall study results. The Kaplan Meier curves in Figure 21 show that the majority of subjects
with ROSC do not survive post-hospitalization out-of-hospital cardiac arrest. However, the Kaplan
Meier estimate of survival at one year was 30% higher in subjects in the ITT population receiving
CPR with the ResQCPR System compared with S-CPR (22.7% vs. 17.5%).
Figure 21: Kaplan Meier Analysis of Subjects with ROSC Following
Out-of-Hospital Cardiac Arrest
Importantly, there was no increase in the number of subjects with severe neurologic impairment
in the ResQCPR group, that is, the neurological outcome in patients who received CPR with the
ResQCPR System appeared to be no worse than the control (S-CPR). In the mITT, proportional
differences between the two treatment groups were observed to become larger over time.
Approximately 50% more subjects receiving CPR with the ResQCPR System were alive one year
after OHCA compared with those treated with S-CPR. However, this comparison was not
prospectively specified or adjusted for multiplicity.
Secondary Safety Endpoint
The analysis of safety was based on the randomized cohort of 2470 subjects in the ITT population
and 1655 subjects in the mITT subgroup available for the evaluation prior to hospital discharge.
The safety analysis included major adverse events that were reported during the pre-hospital
resuscitation effort and up to the point of hospital discharge, as applicable. There were no
differences in overall major adverse event rates between the study groups in the mITT population;
thus the secondary safety endpoint was met. Reported major adverse events by type are shown
in Table 3.
Event
ITT
mITT
S-CPR
(n= 1201)
ResQCPR
(n= 1269)
S-CPR
(n=813)
ResQCPR
(n=842)
Subjects with
≥
1 major
adverse event through
hospital discharge (sec-
ondary safety endpoint
2
)
1129 (94.0)
1194 (94.1)
766 (94.2) 789 (93.7)
Death
1074 (89.4)
1115 (87.9)
729 (89.7) 735 (87.3)
Re-arrest
230 (19.2)
260 (20.5)
161 (19.8) 185 (22.0)
Stroke/cerebral bleeding
11 (0.9)
11 (0.9)
3 (0.4)
2 (0.2)
Internal organ injury
2 (0.2)
2 (0.2)
0 (0.0)
1 (0.1)
Hemothorax
3 (0.3)
3 (0.2)
1(0.1)
2 (0.2)
Bleeding requiring
intervention
8 (0.7)
17 (1.3)
3 (0.4)
7 (0.8)
Cardiac tamponade
4 (0.3)
5 (0.4)
3 (0.4)
2 (0.2)
Aspiration
20 (1.7)
16 (1.3)
7 (0.9)
8 (1.0)
Pneumothorax
11 (0.9)
13 (1.0)
7 (0.9)
10 (1.2)
Seizure
19 (1.6)
23 (1.8)
13 (1.6)
11 (1.3)
Rib/Sternal fracture
23 (1.9)
18 (1.4)
14 (1.7)
11 (1.3)
Pulmonary edema
3
96 (8.0)
143 (11.3)
62 (7.6)
94 (11.2)
1
Numbers shown are subjects with at least one report of the listed adverse event types. If multiple events of same type were
reported, the event is only counted once per subject. Reports of deaths, re-arrest, seizure, and pulmonary edema in the field
(e.g., pre-hospital) are also shown. All other adverse event types were assessed based on review of medical records for
subjects transported to a hospital. There were no Major Adverse Events associated with device malfunctions, defects, or
failures.
2
Secondary safety endpoint: The rate of major adverse events in the ResQCPR group (mITT) was found to be non-inferior to
that in S-CPR group (p < 0.0001) within a non-inferiority margin of 5%.
3
Data shown includes combined pre-hospital and in-hospital reports of pulmonary edema. Pulmonary edema was defined
as any of the following:
Pre-hospital reports
of advanced airway filled with fluid
≥
2 times; blood, mucous, fluid or other
secretions in the airway; reports of pulmonary edema or pleural/pulmonary effusion on post-mortem examinations; and, for
subjects transported to a hospital,
in-hospital reports
of pulmonary edema or pleural/pulmonary effusion confirmed on x-ray
or CT scan. Pre-hospital pulmonary edema was reported in 22 patients (2.7%) in the S-CPR group, and in 30 patients (3.6%)
in the ResQCPR group (mITT).
The only difference in adverse events between the two groups was the observation that more
patients receiving CPR with the ResQCPR System had pulmonary edema. A post hoc analysis
appeared to demonstrate that the presence of pulmonary edema did not adversely affect
effectiveness as measured by survival.
Secondary CASI Effectiveness Endpoint
The pre-specified secondary effectiveness endpoint was an evaluation of long-term neurological
function using Mean Cognitive Abilities Screening Instrument (CASI) scores at 90 and 365 days.
The study was not able to demonstrate an improvement in neurologic function in the ResQCPR arm
based upon CASI scores (as was hypothesized); however, CASI scores were not significantly
different among survivors who were discharged from the hospital. The mean scores included
subjects who died after hospital discharge, with a CASI score equal to 0 assigned to those who
died. More than 85% of the one-year survivors in both study arms completed the one-year CASI
assessment and the mean CASI scores for these subjects were 93.7 ± 11.8 (n=30) in the S-CPR
arm and 94.7 ± 4.4 (n=41) in the ResQCPR arm for the mITT population, consistent with full or
nearly full recovery in both groups; ITT scores were 91.9 ± 13.5 (n=43) in the S-CPR arm and
92.3 ± 12.3 (n=49) in the ResQCPR arm.. There were only three patients with CASI scores <70,
a score consistent with poor neurological function, in both groups. There is limitation in interpreting
the comparison of these CASI results between groups, since the comparison is not based on all
randomized patients but rather is conditional on the survival of subjects at 90 days or 1 year.
Subjects with a Drug/Medication Overdose
A post-hoc analysis of subjects with a presumed medication or drug overdose, as determined by
CEC adjudication, suggested that CPR using the ResQCPR System in this patient population may
have resulted in unfavorable clinical results for drug/medication overdose patients as compared to
both 1) S-CPR for drug/medication overdose patients, and 2) CPR utilizing the ResQCPR System
for non-traumatic arrest patients not having drug/medication overdose as the arrest etiology.
Among S-CPR and ResQCPR subjects with drug/medication overdose arrest etiologies, 20% of
S-CPR (13/65) and 14% of ResQCPR (14/97) subjects survived to hospital discharge.
Overall Conclusions
The results of the pivotal trial demonstrate that the ResQCPR System increased the likelihood of
survival after non-traumatic out-of-hospital cardiac arrest when compared with manual S-CPR, the
current standard of care for treatment of out-of-hospital cardiac arrest in the United States today.
One year survival rates were relatively 34% higher when CPR was performed with the ResQCPR
System compared with S-CPR for all subjects in the ITT population (7.8% vs. 5.8%), and relatively
49% higher for those in the mITT population (9.0% vs. 6.0%). These principal data elements that
led to device approval by FDA, and are accordingly represented in the labeling and indications
for use for the ResQCPR System, were a post hoc analysis of survival not incorporating the
consideration of neurological function. One year after OHCA, more than 95% of surviving
subjects in both treatment groups had excellent neurological function, as determined by cognitive,
functional, and quality of life testing. In cardiac arrest of etiology known to be drug/medication
overdose, the favorable results with use of the ResQCPR System may not be present.
RESQPOD ITD 16 TECHNICAL SPECIFICATIONS
Operating Specifications
Safety check valve threshold
–16 cmH
2
O
Expiratory airway impedance
<5 cmH
2
O
Timing assist lights flash rate
10/min
Shelf Life
Four years
Temperature Range
Operation
-18º to 50º C (0º to 122º F)
Storage
-40 to 60º C (-40º to 140º F)
Dimensions
Height
8.2 cm
Diameter
5.3 cm
Circumference
16.6 cm
Patient side connection
15 mm ID/22 mm OD
Ventilation side connection
22 mm ID
Dead space
41 ml
Weight
62 gm
Materials
Exterior housing and interior molded components
Polycarbonate
Diaphragm and safety check valve gasket
Silicone
Safety check valve spring
Nickel plated stainless steel
Battery
3 V disposable lithium ion coin cell
ResQPOD and ResQPUMP are registered trademarks of Advanced Circulatory. These products and
their use are protected by one or more of the following patents: USA – 5,645,522; 6,155,257;
6,224,562; 6,234,985; 6,312,399; 6,425,393; 6,463,327; 6,587,726; 8,151,790.
Foreign – CNZL96193712.2; EP0898485 (France, Germany, Italy, Sweden, United Kingdom).
Other USA and country patents pending.
RESQPUMP ACD-CPR DEVICE TECHNICAL SPECIFICATIONS
Operating Specifications
Force gauge compression range
0 - 50 kgs ± 15%
Force gauge decompression range
0 - 15 kgs ± 15%
Metronome Function
Signal pitches
768 Hz (low) and 3070 Hz (high)
Sound level
≥
65 dB at distance of 0.5 m for sound source
Rate
80/min
Temperature Range
Operation
-18º to 50º C (0º to 122º F)
Storage
-40 to 60º C (-40º to 140º F)
Dimensions
Suction cup
13.5 cm OD
Height
17.0 cm
Weight
0.58 kg (1.28 lb)
Materials
Suction cup and cushion pad
Silicone
Handle and support ring
Polyamide (nylon), glass fiber reinforced
Connection stem
Acetal polyoxymethylene
Support ring
Thermoplastic polyester elastomer
Metal parts
Stainless steel and brass
Battery
3.6 V primary lithium-thionyl chloride
ACCESSORIES AND REPLACEMENT COMPONENTS AVAILABLE
FOR THE RESQCPR SYSTEM
Reorder #
Description
12-0825-000
ResQCPR System (one ResQPUMP; two ResQPODs)
12-0822-000
ResQPOD ITD 16 (single device)
12-0823-000
ResQPUMP ACD-CPR Device (single device)
12-0586-000
Suction Cup for ACD-CPR Device (replacement suction
cup with support ring and compression cushion)
12-0935-000
ResQCPR Carrying Case (holds one ResQPUMP and two ResQPODs)
Table 3: ResQTRIAL (Out-of-Hospital Cardiac Arrest) Subjects with Major Adverse
Events Through Hospital Discharge
1
LIMITED WARRANTY
Subject to the terms, conditions and limitations contained herein, Advanced Circulatory warrants only to the
ultimate user of the product that Advanced Circulatory’s products will not fail to operate in accordance with their
specifications due to defects in material or workmanship during the time period listed below. The foregoing period
is sometimes referred to as the “original warranty period.” The foregoing limited warranty does not apply to any
part, portion, or component of any product which is manufactured by a third-party (“Third-Party Component”). The
time period for the warranty begins on the date of delivery of the product to the first purchaser. ResQPOD: Period
ending on the earlier of the date of first use or the expiration date on the package for the product provided by
Advanced Circulatory. ResQPUMP: 12 months
THE LIMITED WARRANTY SET FORTH IN THE FOREGOING PARAGRAPH, IS THE SOLE AND EXCLUSIVE
WARRANTY WITH RESPECT TO ADVANCED CIRCULATORY’S PRODUCTS. ADVANCED CIRCULATORY
MAKES NO OTHER EXPRESS WARRANTY OF ANY KIND OR NATURE AS TO THE PRODUCTS OR THEIR
PERFORMANCE EXCEPT FOR THOSE LIMITED WARRANTIES EXPRESSLY SET FORTH IN THE FOREGOING
PARAGRAPH AND EXCEPT THEREFORE, SPECIFICALLY DISCLAIMS ANY AND ALL REPRESENTATIONS OR
WARRANTIES OF ANY KIND OR NATURE CONCERNING THE PRODUCTS, INCLUDING, BUT NOT LIMITED
TO, ANY REPRESENTATION OR WARRANTY THAT THE PRODUCTS COMPLY WITH ANY LAW, OR THAT ANY
PARTICULAR RESULT WILL BE OBTAINED BY USING THE PRODUCTS. ADVANCED CIRCULATORY MAKES NO
WARRANTIES WITH RESPECT TO ANY THIRD PARTY COMPONENT AND ADVANCED CIRCULATORY
SPECIFICALLY SELLS SUCH THIRD-PARTY COMPONENTS “AS IS” WITHOUT ANY WARRANTY. FURTHER,
ADVANCED CIRCULATORY MAKES NO IMPLIED WARRANTY OF ANY KIND OR NATURE WITH RESPECT
TO ITS PRODUCTS OR ANY THIRD-PARTY COMPONENT AND SPECIFICALLY DISCLAIMERS ANY AND
ALL IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, ANY AND ALL IMPLIED WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR COMPLIANCE WITH
ANY FEDERAL, STATE OR LOCAL LAW, RULE OR REGULATION. IN ADDITION, ADVANCED CIRCULATORY
EXPRESSLY DISCLAIMS TO THE FULLEST EXTENT ALLOWED BY LAW, RULE OR REGULATION ANY WARRANTY
PROVIDED UNDER ANY LAW.
The limited warranties set forth above shall be null and void if (a) any alterations or modifications are made to
a product, (b) a product is not maintained in strict compliance with the maintenance requirements set forth in the
maintenance manual for such product or otherwise provided by Advanced Circulatory, (c) any repairs are made
to a product which are not authorized by Advanced Circulatory in writing, (d) any failure of a product to comply
with the above limited warranty is not reported to Advanced Circulatory in writing within thirty (30) days of the
date such failure first occurs, (e) a product is operated after the failure of any warranty first occurs, (f) a product is
used for any purpose other than for the purpose for which it was manufactured, (g) a product is not operated in
strict compliance with the terms and conditions set forth in any operating manual, notice or other statement
accompanying the product, (h) a product is abused or damaged, (i) purchaser fails to deliver the product to
Advanced Circulatory for inspection and testing if requested by Advanced Circulatory or purchaser disposes of
the product or any part or component on or before the thirtieth (30th) day after sending a written claim under the
warranty to Advanced Circulatory, (j) such failure of the limited warranty results from a failure of any third party
component, or (k) a product is not stored or handled as directed in writing by Advanced Circulatory.
The sole and exclusive remedy for any failure of any product to comply with the limited warranty set forth above
or any other warranty imposed upon Advanced Circulatory by Law, if any, shall, at the election of Advanced
Circulatory, in its sole discretion, be either (a) the repair or replacement of the product or component which failed
to comply with such warranty or (b) the refund of the purchase price of the product. Except as provided below,
any repair or replacement shall carry the same warranty as the original product but only for the remainder of the
original warranty period. Purchaser’s exclusive remedy with respect to any claim arising out of or as a result of
third-party component shall be against the third-party manufacturer.
Any and all claims under the above limited warranty shall be made to Advanced Circulatory only in writing and
not later than thirty (30) days after the date the product first fails to comply with the above limited warranty but in
no event later than the expiration of the original warranty period with respect to which the claim is being made.
Any claim under the above limited warranty made after such period for making a claim shall be null and void.
After receiving written notice of the warranty claim, Advanced Circulatory shall determine whether to (a) repair
or replace the product or part or (b) refund the purchase price of the product. Advanced Circulatory may require
purchaser to return any Product or component thereof which purchaser claims to be defective to Advanced
Circulatory at purchaser’s cost for inspection as a condition to any claim under the above limited warranty.
No product or part may be returned to Advanced Circulatory without Advanced Circulatory’s prior written
authorization. If a product which is returned is determined by Advanced Circulatory in its sole discretion not to
have failed to comply with the limited warranty, purchaser shall pay costs of removal, repair and/or replacement
for such product. If a product which is returned is determined by Advanced Circulatory n its sole discretion to have
failed to comply with the limited warranty, Advanced Circulatory shall pay for all repair and/or replacement costs
for such product (or refund the purchase price if so elected by Advanced Circulatory) and Advanced Circulatory
shall reimburse purchaser for the reasonable costs of shipping the product or component to purchaser.
17-0829-000, 08
Manufactured by:
Advanced Circulatory
1905 County Road C West, Roseville, MN
55113 USA
Telephone: 651-403-5600
Customer service: 1-877-737-7763
Email: [email protected]
Website: AdvancedCirculatory.com
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