Precautions; Potential Adverse Events; Clinical Studies; English / English - Spectranetics Turbo-Power Gebrauchsanweisung

5.

PRECAUTIONS

• DO NOT resterilize or reuse this device, as these actions can compromise device performance or increase the risk of cross-contamination
due to inappropriate reprocessing. Reuse of this single use device could lead to serious patient injury or death and voids
manufacturer warranties.
• This catheter has been sterilized using Ethylene Oxide and is supplied STERILE. The device is designated and intended for SINGLE USE ONLY
and cannot be re-sterilized and/or reused.
• The sterility of the product is guaranteed only if the package is unopened and undamaged. Prior to use, visually inspect the sterile package
to ensure that the seals have not been broken. Do not use the catheter if the integrity of the package has been compromised.
• Always store the devices in a cool, dry place (5 to 95% relative humidity, non-condensing). Protect the device from direct sunlight and high
temperatures (storage temperatures 0°C to 60°C). Store device in areas with 11 kPa to 111 kPa atmospheric pressure.
• Device operates at temperatures of 10°C to 40°C in areas with 30 to 75% relative humidity (non-condensing) in areas with atmospheric
pressure of 70 kPa to 106 kPa and is rated as a continuous mode operating device.
• Do not use the Turbo-Power System if any damage is observed or the red error indicator light activates.
• Do not use the Turbo-Power System in an oxygen rich environment.
• Do not use the device if its "Use By" located on the package labeling has passed.
• Read the Operator's Manual thoroughly before operating the CVX-300™ Excimer Laser System or Philips Laser System to ensure safe
operation of the laser system.
• The proximal coupler of the laser catheter connects only to the laser system and is not meant to have any patient contact.
• During device calibration, ensure the laser catheter tip is dry. A wet laser catheter tip may prevent successful device calibration.
• During the procedure, appropriate anticoagulant and vasodilator therapy should be provided to the patient per the institution's
interventional protocols.
• Ensure contrast media has been ushed from the intended vessel and treatment site prior to activating the laser system.
• When infusing through the guidewire lumen, do not exceed an infusion rate greater than 0.5mL/second, or a pressure greater than 131 psi.
• Device rated Type CF de brillation proof with post de brillation recovery time of 500 ms. Disconnect catheter from the laser system before
de brillation.
• Device is rated for IPX2 uid interaction.
• The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in
a residential environment (for which CISPR 11 class B is normally required) this equipment might not o er adequate protection to radio-
frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
• After use, all equipment should be disposed of properly in accordance with speci c requirements relating to hospital waste, local
regulations, and potentially biohazardous materials.
Table 5.1: Guidance and Manufacturer's Declaration - Electromagnetic Emissions
The Turbo-Power System is intended for use in the electromagnetic environment speci ed below. The customer or the user of the Turbo-Power
System should assure that it is used in such an environment.
Emissions Test Compliance
RF emissions Group 1 The Turbo-Power System uses RF energy only for its internal function. Therefore, its RF emissions
CISPR 11 Class A are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions Group 1
CISPR 11 Class A
Harmonic Emissions
Class A
IEC 61000-3-2 The Turbo-Power System does not connect to AC power supplies.
Voltage Fluctuations/
icker emissions Complies
IEC 61000-3-3
Table 5.2: Guidance and Manufacturer's Declaration- Electromagnetic Immunity
The Turbo-Power System is intended for use in the electromagnetic environment speci ed below. The customer or the user of the Turbo-Power
System should assure that it is used in such an environment.
IEC 60601
Immunity Test
Test Level
Electrostatic Discharge (ESD) ± 8 kV contact
IEC 61000-4-2 ± 2, ± 4, ± 8, ± 15 kV air
Electrical Fast Transient/Burst + 2 kV, 100kHz for power supply lines
IEC 61000-4-4 +1 kV, 100 kHz for input/output lines
Surge ±1 kV line(s) to line(s)
IEC 61000-4-5 ±2 kV line(s) to earth
0% U U U
T T
(100% dip in U U ) for 0,5 cycle U
Voltage Dips, short T T
interruptions and voltage
0% U U U
T T
variations on power supply
(100% dip in U U U ) for 1 cycle
T T
input lines.
70% U U U
T T
(30% dip in U U ) for 25/30 cycles U
IEC 61000-4-11
T T
0% U U U
T T
(100% dip in U U U ) for 250/300 cycles
T T
Power Frequency (50/60Hz)
magnetic eld
30 A/m
IEC 61000-4-8
NOTE: U U U is the ac mains voltage prior to application of the test level. is the ac mains voltage prior to application of the test level.
T T T T
P015612-03 13APR21 (2021-04-13)
Turbo-Power™ Laser Atherectomy Catheter
Electromagnetic environment - guidance
Compliance Level Electromagnetic environment- guidance
± 8 kV contact Floors should be wood, concrete or
ceramic tile. If oors are covered with
synthetic material, the relative humidity
± 2, ± 4, ± 8, ± 15 kV air
should be at least 30%.
Mains power quality should be that
Not applicable of a typical commercial or hospital
environment.
Mains power quality should be that
Not applicable of a typical commercial or hospital
environment
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
Turbo-Power System requires continued
Not applicable
operation during power mains
interruptions, it is recommended that the
Turbo-Power System be powered from an
uninterruptible power supply or a battery.
Power frequency magnetic elds should
be at levels characteristic of a typical
30 A/m
location in a typical commercial or hospital
environment.
Table 5.3: Guidance and manufacturer's declaration – Electromagnetic Immunity
The Turbo-Power System is intended for use in the electromagnetic environment speci ed below. The customer or the user of the Turbo-Power
System should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level
3 V rms 3 V rms 150 kHz to
Conducted RF 150 kHz to 80 MHz 80 MHz
IEC 61000-4-6
6 V rms ISM Bands 6 V rms 150kHz to 80
between 150 kHz and MHz
80 MHz
3 V/m 3 V/m
80 MHZ to 2.7 GHz
Telecommunication
frequencies as
speci ed in clause 8.10
of IEC 60601-1-2:2014:
Radiated RF IEC
450, 810, 870, 930, 28 V/m
61000-4-3
1720, 1845, 1970, 2450
MHz at 28 V/m
385 MHz at 27 V/m 27 V/m
9 V/m
710, 745, 780, 5240,
5500, 5785 MHz at
9 V/m
6.

POTENTIAL ADVERSE EVENTS

No long-term adverse e ects on the arterial vessel wall, due to peripheral excimer laser recanalization, are known at this time.
Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications listed below.
Complications may occur at any time during and/or after the procedure.
Potential complications include but are not limited to: perforation of the vessel wall, major dissection, pseudoaneurysm, arteriovenous stula, spasm,
distal embolization, thrombosis, reocclusion, hematoma at the puncture site, bleeding or Acute Limb Ischemia (ALI), any of which may require a
reintervention, bypass surgery or amputation; infection, renal failure, nerve injury, stroke, myocardial infarction, arrhythmia, death and other.
7.

CLINICAL STUDIES

The devices in these studies were used with the CVX-300® Excimer Laser System. The Philips Laser System provides the same output and operates at
the same parameters as the CVX-300® Excimer Laser System; therefore, no new clinical data has been collected for the Turbo-Power Laser Atherectomy
Catheter with the Philips Laser System.
7.1
ABLATE Study
Purpose: This trial evaluated the safety and e ectiveness of the Turbo-Elite in atherectomy treatment for infrainguinal arteries with appropriate catheter
to vessel sizing. Turbo-Elite was used to treat de novo and restenotic lesions in the super cial femoral artery, popliteal and infrapopliteal arteries.
Physicians could also use adjunctive therapies, as necessary, as part of the patient treatments.
Methods: This trial is a non-randomized study evaluating the safety and e ectiveness of Excimer Laser Atherectomy (ELA) using the Turbo-Elite.
The primary safety endpoint was percent freedom from MAE through 30 day follow-up. An MAE is de ned as all cause death, major amputation in the
target limb, or target lesion revascularization. The primary e ectiveness endpoint is de ned as a mean reduction in percent stenosis at the time of the
procedure by Angiographic Core Lab assessment.
Description of Patients: This prospective, multicenter, trial enrolled 44 patients at 10 investigative sites. Baseline patient characteristics,
including demographics, medical history, and risk factors, were comparable between site assessment and core lab assessment. Patients were
predominantly male (53.5%), white (95.3%) and elderly (age: 69.3 ± 10.7yr). The most common comorbidities/risk factors were hyperlipidemia (93.0%),
hypertension (90.7%), smoking history (81.4%), and history of coronary artery disease (CAD) (60.5%). By core lab assessment, mean lesion length was
94.7 ± 73.0mm, reference vessel diameter was 4.7 ± 1.2mm, and % diameter stenosis (%DS) was 80.0 ± 16.5%.
Results: The primary safety endpoint of this study was met. The primary safety hypothesis was that the 30 day freedom from Major Adverse Event (MAE)
rate would be greater than 80%, which included all-cause death, major amputation in the target limb, or target lesion revascularization (TLR). The 30-day
freedom from MAE rate was 97.4%.
The primary e ectiveness endpoint of this study was met. The primary e ectiveness endpoint was a mean reduction in percent diameter stenosis (%DS)
at the time of the procedure by Angiographic Core Lab assessment (average di erence between baseline %DS and post Turbo-Elite %DS). The primary
e ectiveness analysis of the average mean reduction in stenosis post Turbo-Elite was 45.0% ± 2.4%.
Table 7.1.1 Baseline Patient Characteristics
Screening Clinical
Assessment CRF
Gender (% male)
Age at Screening (years) Age at Screening (years)
Weight (kg)
Height (cm)
History of Hypertension History of Hypertension
History of Hyperlipidemia History of Hyperlipidemia
History of Diabetes Mellitus History of Diabetes Mellitus
-- Insulin Dependent
History of CAD History of CAD
History of CVA History of CVA
Smoking Status:
-- Never
-- Current
-- Stopped -- Stopped
Instructions for Use

English / English

Electromagnetic environment
- guidance
Portable and mobile RF communications equipment should be used no
closer to any part of the Turbo-Power System including cables, than the
recommended 30 cm (12in) separation distance.
Interference may occur in the vicinity of equipment marked with the
following symbol.
Mean ± SD (N) (Min, Median, Max) or n/N (%)
23/43 (53.5%)
69.3 +/- 10.7 (43) (53.0,67.0,93.0)
82.8 +/- 20.6 (43) (45.5,81.8,140.0)
168.0 +/- 9.1 (43) (147.3,167.6,188.0
39/43 (90.7%)
40/43 (93.0%)
21/43 (48.8%)
10/21 (47.6%)
26/43 (60.5%)
2/43 (4.7%)
8/43 (18.6%)
9/43 (20.9%)
26/43 (60.5%)
5