TONOPORT VI - Operator's Manual - Firmware Version 3.0

Oct 23, 2026

Operator’s manual for GE Healthcare TONOPORT VI ambulatory blood pressure system firmware version 3.0. Specifies that the manual applies only to this firmware release, outlines safety and regulatory information, and defines intended use for non-invasive ambulatory blood pressure monitoring for adults and pregnant patients (not for neonates or intensive-care use). Covers system controls and setup, data output, error codes, software installation, cleaning and maintenance, technical specifications, order information, and electromagnetic compatibility details.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages40

Reading Time1 h 41 min

AccessFree to download

1 Application, Safety Information

1.1 Application Intended use

2 Controls and Indicators

3 Setup

4 Application

5 Data Output

6 Error Codes

7 Software Installation

8 Cleaning, Maintenance, Disposal

9 Technical Specifications

10 Order Information

11 Appendix-Electromagnetic Compatibility (EMC)

GE Healthcare TONOPORT VI Ambulatory Blood Pressure System Firmware Version 3.0 Operator's Manual 2001589-312 ENG Revision A Note The information in this manual only applies to TONOPORT VI, firmware version 3.0. It does not apply to earlier firmware versions. Due to continuing product innovation, specifications in this manual are subject to change without notice. CASE™ is a trademark owned by GE Medical Systems Information Technologies GmbH, a General Electric Company going to market as GE Healthcare. © 2016 General Electric Company. All rights reserved. 1 Application, Safety Information 6 2 Controls and Indicators 10 3 Setup 12 4 Application 18 5 Data Output 23 6 Error Codes 24 7 Software Installation 25 8 Cleaning, Maintenance, Disposal 27 9 Technical Specifications 29 10 Order Information 30 11 Appendix-Electromagnetic Compatibility (EMC) 31 Revision History This manual is subject to the GE Healthcare change order service. The revision code, a letter that follows the document part number, changes with every update of the manual. Part No./Revision 2001589-312 Revision A Date 2017-01 Comment Initial Release General Information 􀁺 The product TONOPORT VI bears the CE marking CE-0482 (notified body MEDCERT GmbH) indicating its compliance with the provisions of the Council Directive 93/42/EEC about medical devices (including amendment 2007/47/EC) and fulfills the essential requirements of Annex I of this directive. It has an internal power source and is an MDD class IIa device. The device fulfills the requirements of the Directive 2011/65/EU ofthe European Parliament and of the Council. 􀁺 It has a type BF applied part. 􀁺 The product fulfills the requirements of the standard EN/IEC 60601-1 "Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance" as well as the electromagnetic immunity requirements of the standard EN/IEC 60601- 1-2 "Medical electrical equipment – Collateral standard: Electromagnetic compatibility – Requirements and tests" and applicable amendments. 􀁺 The product is clinical validated. The validation fulfills the standard ISO 81060-2:2013” Non-invasive sphygmomanometers-Part 2: Clinical investigation of automated measurement type” and the protocol ESH-IP 2010 from the European Society of Hypertension. 􀁺 The radio-interference emitted by this product is within the limits specified in CISPR11/EN 55011, class B. 􀁺 The device is certified by UL and thus also fulfills the UL safety requirements. 􀁺 The CE marking covers only the accessories listed in the "Order Information" chapter. 􀁺 This manual is an integral part of the equipment. It should be available to the equipment operator at all times. Close observance of the information given in the manual is a prerequisite for proper equipment performance and correct operation and ensures patient and operator safety. Please note that information pertinent to several chapters is given only once. Therefore, carefully read the manual once in its entirety. 􀁺 The symbol means: Follow the instructions given in the operator manual. It indicates points which are important to avoid faulty measurements or injuries like strangulation of the arm. 􀁺 This manual reflects the equipment specifications and applicable safety standards valid at the time of printing. All rights are reserved for devices, circuits, techniques, software programs, and names appearing in this manual. 􀁺 On request GE Healthcare will provide a Field Service Manual. 􀁺 The safety information given in this manual is classified as follows: Danger indicates an imminent hazard. If not avoided, the hazard will result in death or serious injury. Warning indicates a hazard. If not avoided, the hazard can result in death or serious injury. Caution indicates a potential hazard. If not avoided, the hazard may result in minor injury and/or product/property damage. 􀁺 To ensure patient safe

FAQs

What is the intended use of TONOPORT VI?

TONOPORT VI is intended for non-invasive ambulatory blood pressure monitoring on adults and pregnant women, following physician consultation and instruction.

Who should not use TONOPORT VI for blood pressure measurements?

It is not suitable for neonatal blood pressure measurements and not intended for use in intensive-care medicine.

How is safety information organized in the manual?

Safety information is classified as Danger, Warning, and Caution, indicating imminent hazards, hazards, and potential hazards respectively, with effects described if not avoided.

Oct 23, 2026

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