Informed Consent Shock Waves General Setoc

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INFORMED CONSENT FOR TREATMENT WITH WAVES

EXTRACORPOREAL SHOCK

PATIENT'S DATA:

Hª No.:................................................ ....
SURNAMES:................................................ ......................................NAME:.......... .....................
GENDER:.................................... AGE:........ ...............BIRTHDATE: ............................
ADDRESS:................................................ .................................................. ....................................
PHONE:................................................ ...

INFORMED CONSENT FOR TREATMENT WITH WAVES


EXTRACORPOREAL SHOCK

I, Mr./Ms. ……………………………………………………………………………… …as a patient or as a


representative of D. ………………………………………………….., in full use of my faculties, free and I voluntarily
DECLARE THAT I HAVE BEEN DULY INFORMED of the objectives that are pursued with this treatment, as well
as the complications that may arise from it and its advantages over other therapeutic possibilities, by virtue of the
rights established by the LAW. GENERAL HEALTH (Law 14/1986, of April 25) and the BASIC LAW
REGULATING PATIENT AUTONOMY, AND RIGHTS AND OBLIGATIONS IN THE FIELD OF CLINICAL
INFORMATION AND DOCUMENTATION (Law 41/2002, of November 14), and Consequently, I AUTHORIZE
the Dr./s to provide me with said treatment. I have had the opportunity to clarify my doubts in a personal interview
with Dr. Karin Freitag.

EXPLANATION OF EXTRACORPOREAL SHOCK WAVE TREATMENT:

The specific treatment with extracorporeal Shock Waves is applied on an outpatient basis, therefore not requiring
hospital admission. In treatments on the bone plane, pseudoarthrosis or delayed consolidation, the patient will
be admitted as a control measure for the anesthesia applied. It is a conservative therapeutic process, which has
been used for years and has demonstrated its usefulness and effectiveness in the management of certain painful
processes (tendinopathies in general, shoulder tendonitis, epicondylitis, epitrochleitis, trochanteritis, patellar
tendonitis, Achilles tendinitis and plantar fasciitis). , as well as in the treatment of pseudoarthrosis and/or delays in
bone consolidation.

In your case, you will be treated for a condition diagnosed with:


………………………..........................................................................................................................................

It is applied through an extracorporeal Shock Wave generator, based on a transducer that, through an
/electromagnetic/piezoelectric/electrohydraulic/ phenomenon, transforms electrical energy into sonic energy. The
generated shock wave is transmitted through a degassed aqueous medium contained between the generator and a
membrane. We use technology with ultrasonic/radiological/laser/locator that allows us to correctly locate the area to
be treated.

Informed consent for treatment with extracorporeal Shock Waves.

TYPICAL RISKS OF EXTRACORPOREAL SHOCK WAVE TREATMENT:


[Write text]
INFORMED CONSENT FOR TREATMENT WITH WAVES
EXTRACORPOREAL SHOCK

1. Hematomas: The appearance of hematomas in the area of application of Shock Waves is not common, except in
those patients who present some type of blood coagulation disorder. If they do appear, they are usually limited to the
application area and generally disappear within a few days.

2. Skin erythema: Sometimes, dermal alterations in the form of erythema may appear in the area of application of
Shock Waves, although their appearance is infrequent and they usually disappear in a few days.

3. Subsequent situations and discomforts derived from this treatment, such as pain in the application area, general
discomfort and lack of symptomatic improvement.

4. The pain usually appears within hours of the treatment and remains during the treatment phase.
It should be treated with usual analgesics or anti-inflammatories.

In the case of increased pain and/or appearance of local inflammation at the site of Shock Wave application in the
hours following the treatment, it is recommended to take regular analgesics, apply local cold and rest the area. treated.
The evolution of the process is slow both in the application of the soft tissues, tendonitis with or without calcification
and in the bony parts to be treated and the final result is in the medium term, objective improvement beginning
approximately after the sixth week. Each patient presents a different evolution over time that will be evaluated in each
particular case. We cannot guarantee results given the processes in which we are immersed. Each patient has a
different previous evolution and therefore the evolution will be different.

SECTION TO COLLECT THE PERSONALIZED RISKS AND CONTRAINDICATIONS OWN FOR EACH
PATIENT:

In addition to the risks described above, the following risks exist due to your personal circumstances (medical or
otherwise):

SECTION FOR COMPLEMENTARY CLINICAL EXPLANATIONS:

I declare that I am satisfied with the information that has been provided to me (benefits, risks, alternatives, etc...) and I
understand that this document, which will be integrated into my medical record , can be revoked by me at any time,
before the carrying out the procedure.

And for the record, I sign this document after reading it.

In Madrid, at......... of ….................... of 20....................

Signature of the patient Signature of the witness: Signature of the reporting Physician:
(or legal representative): Dr.

DNI: DNI: DNI:


Informed consent for treatment with extracorporeal Shock Waves.
SECTION TO COLLECT THE REVOCATION OF CONSENT:

D./D.ª…………………………………………………………, with DNI in my capacity as…………………………


(patient/representative), I revoke the prior consent granted . I made this decision despite having been sufficiently
informed of the risks to which I am subject by not being treated.

[Write text]
INFORMED CONSENT FOR TREATMENT WITH WAVES
EXTRACORPOREAL SHOCK

In………...............………. to…...... of..........…………............ of 20....…...

Signature:
ID:

SECTION TO RECORD THE DENIAL OF CONSENT:

D./Ms.………………………………………., with DNI In my capacity as...............(patient/representative), I do not


authorize the performance of the procedure that has been proposed to me. I made this decision despite having
been sufficiently informed of the risks to which I am subject by not being treated.

In…………................……. to…. of ….................… of 20......…......

Signature:
ID:

Informed consent for treatment with extracorporeal Shock Waves.

NAME OF PATIENT:.............................................. .................................................. ....

DIAGNOSIS:................................................ .................................................. ....................

Session Date:

[Write text]
INFORMED CONSENT FOR TREATMENT WITH WAVES
EXTRACORPOREAL SHOCK

1st................................................. .........

2nd................................................. ........

3rd................................................. ........

Successive:..............................................

** ADD
INFORMATION CLAUSE (LOPD) OF THE PRODUCTION CENTER

In compliance with the provisions of article 5 of Organic Law 15/1999, of December 13, on the Protection of Personal Data
(LOPD), .................. .................................................. .......

Informed consent for treatment with extracorporeal Shock Waves.

[Write text]

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