DWG-01-034 Rev. A - ©2021
3
2
DWG-01-034 Rev. B - ©January 2021
Instructions for Use -
HAART 201 Instrument Set
Table of Contents
1. Instrument Labeling Symbols .......................................2
2. Indications ...................................................................2
3. Description ...................................................................2
4. Warnings .....................................................................3
5. Precautions ..................................................................4
6. How Supplied ..............................................................4
7. Directions for Use ........................................................5
8. Sizer and Gage Sphere Accuracy Statement ..............5
9. Cleaning and Sterilization Prior to Use ........................5
Disclaimer of Warranties .................................................7
Patents ............................................................................8
Figures ..........................................................................117
1. Instrument Labeling Symbols
Consult Instructions for Use
Authorized European Rep
Product complies with requirements of directive
93/42/EEC for medical devices
Batch code
Catalog number
Nonsterile
Manufacturer
2. Indications
The HAART 201 Instrument Set is intended to be used
as an aid in the implantation of the HAART 200 Aortic
Annuloplasty Device.
3. Description
The HAART 201 Instrument Set consists of four (4)
Sizers, one (1) Gage Sphere, and two (2) Handles
provided in a stainless steel tray (Figure 1 on page 117).
The Instrument Set is used to select the proper HAART
200 Aortic Annuloplasty Device size for a given patient
and to assist in the assessment of leaflet coaptation
after completion of the overall repair of the aortic valve.
The HAART 201 Instrument Set is reusable; however,
it must be cleaned and sterilized by autoclave (steam)
prior to each use. Refer to the sections below for detailed
information on accessory use and sterilization.
3.1 Handle
The Handle is machined from ASTM A276 stainless steel,
and cleaned and passivated per ASTM specification
F86. The Handle may be threaded into the Sizers, Gage
Sphere, and Holder to facilitate positioning during the
procedure (Figure 2 on page 117). The stainless steel
Handle may be bent in the narrowed section to present
the Sizers, Gage Sphere, and Device to the surgical site in
the desired manner. The Handle is very similar in design
and manufacture to handles supplied with replacement
heart valve prostheses and is intended to be used in a
similar manner.
3.2 Sizers
The Sizers are machined from polyphenylsulfone. Each
Sphere has a through hole along its axis (Figure 3 on
page 118). The top of the through hole is threaded to
receive the instrument Handle.
The Sizers are laser marked with a line at the equator and
15° wide stippled regions, oriented 180° apart, to assist
the user with assessment of leaflet free-edge length.
The size of the corresponding HAART 200 device is
prominently marked on the upper surface of each Sizer.
3.3 Gage Sphere
The Gage Sphere is machined from polyphenylsulfone
and has a through hole along its axis. The top of the
through hole is threaded to receive the instrument Handle.
After completion of leaflet repair, effective height and
leaflet geometric height may be assessed using the
Gage Sphere provided in the HAART 201 Instrument
Set. The Gage Sphere has two different vertical scales
marked on the surface (Figure 4 on page 119). One scale
originates at the apex of the Sphere and is intended for
estimating the effective height of the valve leaflet. For
a successful repair, leaflet effective height should be
approximately 8 to 10 mm. The second scale may be
used to assess leaflet geometric heights, when desired,
for further evaluation of leaflet size and symmetry after
the overall valve repair.
4. Warnings
Do not use other manufacturer’s annuloplasty sizers.
Other annuloplasty sizers may not indicate the appropriate
HAART 200 Aortic Annuloplasty Device size.
MD
2
DWG-01-034 Rev. A - ©2021
