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computer for analysis and interpretation.
Blood pressure measurements determined with this device are equivalent to those obtained by a
trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the
ISO 81060-2.
SAFETY and EFFECTIVENESS WARNINGS
Make sure that you are familiar with all Safety and Effectiveness considerations before using the
ABPM (model - ACCUNIQ BP800).
ACCESSORIES
The SELVAS Healthcare, Inc.
warranty can only be honored if you use SELVAS Healthcare, Inc.
approved accessories and replacement parts.
Caution
Use of accessories other than those recommended by SELVAS Healthcare, Inc. may
compromise product performance.
2. WORD DEFINITIONS
SYS
Systolic Blood Pressure
DIA
Diastolic Blood Pressure
Exhaust
This means "releasing the cuff air as soon as possible".
3. CLASSIFICATION AND COMPLIANCE
1) This device is classified as;
- Battery powered and the type-BF against electric shock
- Ordinary equipment without protection against ingress of water
- Equipment not suitable for use in presence of a flammable anesthetic mixture by standard of IEC
60601-1:2005(Safety of Medical Electrical Equipment)
2) This device is in compliance with Class A for Noise-Emission, Level B for Noise-immunity, by
standard of IEC 60601-1-2:2007(Electromagnetic Compatibility Requirements).
3) This device complies with:
-
IEC 60601-1:2005 Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
-
IEC 60601-2-30
Medical electrical equipment -- Part 2-30: Particular requirements for basic
safety and essential performance of automated non-invasive sphygmomanometers
- ISO 81060-1: 2007 Non-invasive sphygmomanometers — Part 1: Requirements and test
methods for non-automated measurement type
-
ISO 81060-2:2009
Non-invasive sphygmomanometers -- Part 2: Clinical validation of
automated measurement type
-
ISO 10993-1:
Biological evaluation of medical devices
4. SAFETY PRECAUTIONS
This device is designed and manufactured with consideration of safety of the operator and
patient and also to the reliability of the unit.
The following precautions must be observed for additional safety;
1) The unit must be operated only by, or under supervision of a qualified person.
2) The operator and patient must not touch or handle inner side of the equipment at any time.
3) Do not modify the unit. If any modification is needed, ask our company or its authorized dealer for
Summary of Contents for BP800
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