Itamar Medical EndoPAT 2000, Руководство по эксплуатации

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Itamar Medical Ltd.
Endo PAT
TM
x Device 3 Operation Manual

Patient referred to diagnostic angiography

Normal or near normal angiogram (< 30% stenosis)

Evaluation in catheterization laboratory

Signed informed consent
Criteria for exclusion:

Deformities of fingers that preclude adequate signal acquisition with the
EndoPAT
TM 2000 device.

Short acting NTG less than 6 hours prior to study and calcium channel blockers
or alpha-blockers less than 24 hours prior to study.
1.3 Equipment Classification
The EndoPAT
TM
x device is classified as a Class IIa medical device in accordance with Rule
10 of Annex IX of the Medical Device Directive 93/42 EEC, 2007/47/EC
1.4 Manufacturers Notice
The information in this document is subject to change without notice.
Itamar Medical Ltd. makes no warranty of any kind on this material, including but not limited
to, the implied warranties of merchantability and fitness for a particular purpose. Itamar
Medical Ltd. shall not be liable for errors contained herein or for incidental or consequential
damages in connection with the furnishing, performance, or use of this material.
This document contains proprietary information, which is protected by copyright. All rights
reserved. No part of this document may be photocopied, reproduced, or translated without
the prior written consent of Itamar Medical Ltd.
1.5 Restrictions for Use

Only qualified medical personnel may authorize the use of the EndoPAT
TM
x device.

In the event of equipment malfunction all repairs should be executed by authorized
Itamar Medical Ltd. personnel or licensed service agents.

The eligibility of a patient for a PAT
™
study is generally based upon the patient’s
medical status. The following should not be considered for the PAT
™
study:
- Deformities of the digits of the upper extremities, which preclude adequate
signal acquisition
- Patients under the effect of short-acting NTG (3 hours washout period)
- Patient suffering from a medical condition prohibiting blood flow occlusion
in both arms. If occlusion is prohibited in only one arm then the reactive
hyperemia procedure that includes the inflation of a blood pressure cuff to a
supra-systolic pressure should be performed on the other arm.

The EndoPAT
TM
x system in whole, or in part, may not be modified in any way.

The device is intended for diagnostic aid purposes only, and should not be used for