Page 1
GE Healthcare TONOPORT V Ambulatory Blood Pressure System Firmware Version 2.2 Operator’s Manual 2001589-085 ENG Revision G...
Page 2
Note The information in this manual only applies to TONOPORT V, firmware version 2.2. 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.
Order Information Appendix - Electromagnetic Compatibility (EMC) 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...
Page 4
General Information General Information The product TONOPORT V bears the CE marking This manual reflects the equipment specifications and CE 0482 (notified body MEDCERT GmbH) applicable safety standards valid at the time of indicating its compliance with the provisions of the printing.
Page 5
PAR Medizintechnik GmbH & Co. KG Rigistr. 11 12277 Berlin Germany Tel. +49 30 235 07 00 Distributor: GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226 USA The country of manufacture appears on the device label. 2001589-085 Revision G...
Also it is not suitable for use in intensive-care medicine. Oscillometric Measuring Method For periods of up to 30 hours, TONOPORT V records the The blood pressure is measured by the oscillometric patient's blood pressure at selectable intervals and saves the method.
Page 7
Application, Safety Information 1.2 Functional Description The TONOPORT V monitor accommodates the blood pressure measuring system and a microprocessor for system control and data processing. The monitor is powered by two AA size batteries (either rechargeable NiMH batteries or alkaline batteries).
Page 8
Compliance with the standard IEC 60601-1 must always be ensured. – TONOPORT V may be connected to CASE™ or to a PC with the CardioSoft program. While connected to any of these devices, TONOPORT V must be disconnected from the patient.
Page 9
– The battery charger is not a medical device. It TONOPORT V complies with the relevant EMC must not be used in the patient environment. requirements. X-ray equipment, MRI devices, –...
Liquid crystal display (LCD) Port for connection to PC (USB) Port for connection to PC (RS232) Calibration mark Lid covering battery compartment (Rechargeable) batteries Fig. 2-1 TONOPORT V controls and indicators ON/OFF switch Functions of the Button INFO Nameplate Button...
Page 11
Polarity of the DC input (charger only) Pollution control symbol according Approval mark for use of the equipment to the Chinese standard SJ/T11363- in a vehicle (charger only, xxx-xx xxxx 2006 alphanumeric characters) Class II equipment For indoor use only 2001589-085 Revision G TONOPORT V...
Setup Setup Some Basic Facts on Battery Power Hold TONOPORT V as shown in Fig. 3-1 and slide the lid of the battery compartment open (approx. TONOPORT V is either powered by two rechargeable 1 cm). Nickel Metal Hydrid batteries (NiMH) or by two alkaline batteries.
Page 13
Otherwise the temperature sensors will not ing the correct polarity. function correctly. If TONOPORT V is powered by rechargeable batteries (4 Two different charger models are available: of them are shipped with the equipment), they should be COMPIT TC4 recharged immediately after use (24 hours).
Page 14
If the batteries are correctly inserted and the displayed battery symbols show no bars, the charger has identified a battery problem. The charging current to the compartment concerned will be cut off. Remove the battery and discard, observing the applicable waste- disposal regulations. TONOPORT V 2001589-085 Revision G...
Page 15
BP monitors that have passed the self-test and completed Briefly switch TONOPORT V off and on again and the battery test will indicate the following information: wait for the time to be displayed.
Page 16
(10 p.m. to 7 a.m.) Setting Date and Time every 15 minutes every 30 minutes Briefly switch TONOPORT V off and on again and wait for the time to be displayed. every 20 minutes every 40 minutes every 30 minutes...
INDEX label when the cuff is closed. The end of the cuff must be situated within this range when the cuff is closed. Latex-free blood pressure cuff. Single-use device. CE marking, cuff fulfills EU regulation. 2001589-085 Revision G TONOPORT V...
Page 18
– the cuff and the TONOPORT V are used inside – By watching the limb it is necessary to check that the ambient conditions for operation and inside...
Page 19
Application Initiate a Trial Measurement Patient Information Turn on TONOPORT V and place it in the carrying Advise your patient pouch. There is an aperture in the pouch to accommo- – not to move while a measurement is being taken to date the cuff connection tube.
Page 20
– arterial or venous vascular access Other diagnostic or therapeutic measures do not negatively affect the blood pressure measurement. Note Professional healthcare personnel have to give the patient some information about the accuracy of the TONOPORT V. TONOPORT V 2001589-085 Revision G...
Page 21
Toggle Manually Between Day and Night Measurement Phase These are the buttons on TONOPORT V used during an In the three measurement protocols the day phase lasts from ambulatory blood pressure measurement: 7 a.m. to 10 p.m. and the night phase from 10 p.m. to 7 a.m.
TONOPORT V is used (a Fig. 5-1) RS232 port – via cable 2001589-011, if the serial port of TONOPORT V is used (b Fig. 5-1) Turn on TONOPORT V and wait for the time to be displayed on TONOPORT V. 2001589-085 Revision G TONOPORT V...
6 mmHg/s. 40 mmHg and no diastolic pressure could be identified (TONOPORT V does not measure diastolic pressures below 40 mmHg). TONOPORT V 2001589-085 Revision G...
CardioSoft pre version 6.6 and the USB driver run under these operating systems: Windows 2000, Windows 5. Turn on TONOPORT V and connect it to the PC, XP Professional, Windows Vista Home Premium 32-bit, using the USB connection cable.
Page 25
Software Installation USB Port Verification For verification of the USB port, turn on TONOPORT V and connect its USB port to the PC. Start the Device Manager of the operating system. Double-click Ports (COM and LPT) to view all ports.
These checks should be performed by persons with let liquid enter the device. adequate training and experience. Caution The checks can be carried out by GE Healthcare within Equipment damage — the framework of a service agreement. Please contact Do not disinfect the device surface with phenol- your local, authorized dealer for details.
Page 27
: the display indicates an internal value that START START STOP STOP must be between 25 and 100. If the displayed value is outside this range, TONOPORT V must be returned for repair. INFO Push again: the display indicates "0" (the dis- START...
– 2 AA size alkaline batteries Battery Charge Time – 2 to 3 hours Maximum Cuff Pressure – 300 mmHg Measuring Method – oscillometric Battery Charger – protection class II, IP20 – 100 to 240 VAC 50/60 Hz, 0.5 A 2001589-085 Revision G TONOPORT V...
Rechargeable NiMH batteries (4, size AA) 2104824-001 Belt for carrying pouch Carrying pouch 2001589-040 Connection cable TONOPORT V to PC Belt for carrying pouch (USB), length approx. 1.5 meters Blood pressure cuff for adults, 2001589-011 Connection cable TONOPORT V to PC standard, width 13 cm, for (RS232), length approx.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions TONOPORT V is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure that TONOPORT V is used in such an environment.
Page 31
Electromagnetic Compatibility (EMC) Guidance and Manufacturer’s Declaration – Electromagnetic Immunity TONOPORT V is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure that TONOPORT V is used in such an environment.
Page 32
Electromagnetic Compatibility (EMC) Guidance and Manufacturer’s Declaration – Electromagnetic Immunity TONOPORT V is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure that TONOPORT V is used in such an environment.
Page 33
RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which TONOPORT V is used exceeds the applicable RF compliance level above, TONOPORT V should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment.
Page 34
Note Any supplied accessories that would not affect electromagnetic compatibility (EMC) are not included. 2001589-011 Connection cable TONOPORT V to PC (RS232), length of 1.2 meters 2001589-040 Connection cable TONOPORT V to PC (USB), length of 1.5 meters 2001589-085 Revision G...
Page 35
Electromagnetic Compatibility (EMC) For your notes TONOPORT V 2001589-085 Revision G...
Page 36
The device measures your systolic, diastolic, and mean arterial blood pressure and your heart rate. The blood pressure is measured with an accuracy ±3 mmHg. The device can record up to 400 blood pressure measurements. Note down here the additional instructions of your doctor: TONOPORT V 2001589-085 Revision G...
Page 37
Explosion hazard Technical inspections of the measuring system Technical safety inspections Technical specifications Time, set Firmware version, view Toggling between night and day phases Function Trial measurement General information USB driver installation USB port, select 2001589-085 Revision G TONOPORT V...
Page 38
Index Warning, definition Weight TONOPORT V 2001589-085 Revision G...
Page 40
PAR Medizintechnik GmbH & Co. KG Rigistr. 11 12277 Berlin Germany Tel: +49 30 2350700 GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226 USA www.gehealthcare.com...