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General Information

6

TONOPORT VI

2001589-312 Revision B

PAR Medizintechnik GmbH & Co. KG
Sachsendamm 6
10829 Berlin, Germany
Germany
Tel. +49 30 235 07 00
Fax +49 30 213 85 42

GE Medical Systems

Information Technologies

, Inc.

9900 Innovation Drive
Wauwatosa, WI 53226 USA

The country of manufacture is indicated on the device la-
bel.

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Summary of Contents for TONOPORT VI

Page 1: ...GE Healthcare TONOPORT VI Ambulatory Blood Pressure System Firmware Version 3 0 Operator s Manual 2001589 312 ENG Revision B ...

Page 2: ... 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 2020 General Electric Company All rights reserved ...

Page 3: ...Information 7 2 Controls and Indicators 11 3 Setup 13 4 Application 19 5 Data Output 24 6 Error Codes 25 7 Software Installation 26 8 Cleaning Maintenance Disposal 27 9 Technical Specifications 29 10 Order Information 30 11 Appendix Electromagnetic Compatibility EMC 31 ...

Page 4: ...ocument part number changes with every update of the manual Part No Revision Date Comment 2001589 312 Revision A 2018 05 Initial Release 2001589 312 Revision B 2020 02 26 Updated for MDR requirements Updated Intended Use section Updated Signs and Symbols section Updated Application section Updated Order Information section Updated Appendix Electromagnetic Compatibility EMC section ...

Page 5: ...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 not...

Page 6: ...Medizintechnik GmbH Co KG Sachsendamm 6 10829 Berlin Germany Germany Tel 49 30 235 07 00 Fax 49 30 213 85 42 GE Medical Systems Information Technologies Inc 9900 Innovation Drive Wauwatosa WI 53226 USA The country of manufacture is indicated on the device la bel ...

Page 7: ...ing deflation of the cuff deflation measurement method or by using a novel and faster technology already during inflation of the cuff inflation measurement method The deflation measurement method is the most common method used With this technique the cuff is inflated to a pressure which must be clearly above the expected systolic value Including cuff inflation the measurement typically takes appro...

Page 8: ...ure in the cuff during a measurement using the inflation measurement method systolic pressure at 125 mmHg diastolic pressure at 83 mmHg With both methods a pressure transducer measures the cuff pressure as well as the superimposed pressure pulsations During blood pressure measurements the cuff must be at heart level If this is not ensured the hydrostatic pressure of the liquid column in the blood ...

Page 9: ...ion of this device to an IT network that includes other equipment could result in previously unidentified risks to patients operators or third parties The responsible organization should identify analyze evaluate and control these risks Changes to the IT network could introduce new risks that require additional analysis Changes to the IT network include changes in network configuration connection ...

Page 10: ...erference as they may emit higher levels of electromagnetic radiation Caution Equipment damage risk to persons Before connecting the battery charger to the power line check that the voltage ratings on the nameplate match those of your local power line The battery charger is not a medical device Its use in the patient environment is not permitted Before using the equipment the operator must ascerta...

Page 11: ...f 3 Calibration mark 4 Liquid crystal display LCD 5 Button push to start and stop a measure ment and to confirm entries 6 Rechargeable batteries 7 Lid covering battery compartment 8 Nameplate 9 Port for connection to PC RS232 10 Port for connection to PC USB 1 2 3 4 5 6 7 8 9 10 Button Mes sage on display Function Push once H 1 clear memory Push twice H 2 set date and time Push 3 times H 3 select ...

Page 12: ...formity to applicable technical regulations of Customs Union MEDICAL PATIENT MONITORING EQUIPMENT AS TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI AAMI ES60601 1 2005 AMD 1 2012 CAN CSA C22 2 No 60601 1 2014 IEC 60601 1 6 2010 A1 2013 IEC 60601 1 11 2015 IEC 80601 2 30 2009 A1 2013 Caution Federal law restricts this device to sale by or on the order of a physician 04...

Page 13: ... xxx xx xxxx alphanumeric characters Protection class II equipment For indoor use only Approval mark for Japan China RoHS pollution control label RoHS Restriction of certain hazardous substances The device fulfills the requirements of the Directive 2011 65 EU RoHS 2 of the European Parliament and of the Council and the amendment EU 2015 863 RoHS 3 of the European Parliament and of the Council E4 x...

Page 14: ...harging NiMH Batteries If TONOPORT VI is powered by rechargeable batteries 4 of them are shipped with the equipment they should be recharged immediately after use 24 hours Use only the original charger supplied It consists of an AC power adapter and the charging unit itself Note The energy source needs to be selected only when the BP monitor is put into service for the first time or when you chang...

Page 15: ...ompartments on the right or on the left The batteries take up to 3 hours to recharge Once the batteries are inserted battery symbols will appear in the charging unit display where each symbol corresponds to one of the charger compartments Fig 3 3 During the charge cycle the corresponding bar in the battery symbols blinks Note If the battery symbols and bar do not light up only one battery may be i...

Page 16: ... have a capacity of 100 i e they are fully charged b 50 means that the alkaline batteries have a capacity of only 50 i e they are half depleted The minimum battery capacity for a 24 hour measurement is 90 If the capacity is below 90 new or fully charged batteries must be inserted BP monitors that have passed the self test and completed the battery test will indicate the following information the t...

Page 17: ...h the display indicates LLLL To delete the data push again the display indicates 0000 followed by the time if you do not wish to clear the memory turn off the BP monitor instead of pushing Selecting the Measurement Method Briefly switch TONOPORT VI off and on again and wait for the time to be displayed Push 9 times the display indicates H 9 Push the display indicates 0000 if the selected method is...

Page 18: ...oice of three different measurement protocols Max inflation pressure day phase 250 mmHg night phase 220 mmHg Selecting a Measurement Protocol Briefly switch TONOPORT VI off and on again and wait for the time to be displayed Push 3 times the display indicates H 3 Push the display indicates LLLL Selecting a protocol automatically clears the memory If you want to retain the data switch the BP monitor...

Page 19: ...ethanol 70 mikrozid universal liquid Buraton rapid Sporicidin or Cidex After disinfection rinse the cuff thoroughly with tap water and air dry Follow the instructions given in the operator manual Blood pressure cuff fits adult patient of the size marked by the frame Standard Small Large or Extra large Blood pressure cuff is suitable for the indicated arm circumference When the blood pressure cuff ...

Page 20: ...s not compress the blood vessels the cuff and the TONOPORT VI are used inside the ambient conditions for operation and inside the measuring range see chapter Technical Specifications Warning Risk to Persons The effect of blood flow interference can result in a harmful injury to the patient caused by continuous cuff pressure due to connection tubing kinking Too frequent measurements can cause injur...

Page 21: ...display when you turn on the device If you still try to initiate a measurement the message LLLL prompts you to clear the memory Push twice to delete the data If you want to retain the data turn off the device instead of pushing To avoid erroneous measurements ensure that the patient does not move during the trial measurement The patient may stand or sit Push to initiate the first measurement Withi...

Page 22: ...ure tubing may only be removed in emergency situations see warning below that cleaning is performed by professional medical personnel and not by the patient Absolute contraindications The application of the cuff is prohibited on an arm with dialysis shunt fresh operation wounds mastectomy Relative contraindications If the doctor ascertains a positive benefit risk ratio the application of the cuff ...

Page 23: ...second measurement The next measurement after error code E06 occurs at the selected interval After error codes E02 and E08 the device enters the power save mode to prevent over discharging of the rechargeable batteries This mode can only be terminated by turning the device off and on again Toggling Between Day and Night Phase In the three measurement protocols the day phase lasts from 7 a m to 10 ...

Page 24: ...t for the time to be displayed For more information about data output please refer to the Operator Manual of CASE CardioSoft When you have finished downloading data to CASE CardioSoft and do not intend to continue working with this system disconnect TONOPORT VI and turn it off Fig 5 1 Connections for PC cable a RS232 port b USB port Warning Risk to Persons Disconnect TONOPORT VI from other equipme...

Page 25: ...sure could be identified TONOPORT VI does not measure diastolic pressures below 40 mmHg E 15 Motion artifact during diastole detection E 17 Internal hardware error Please contact your local authorized dealer http gehealthcare com E 18 Systolic reading outside measuring range E 19 Diastolic reading outside measuring range Codes E 18 and E 19 are displayed when the systolic and diastolic values are ...

Page 26: ...on procedure 5 Turn on TONOPORT VI and connect it to the PC using the USB connection cable Windows will automatically detect TONOPORT VI TUSB3410 device 6 Follow any additional prompts that may be dis played 7 When Windows indicates that the drivers were suc cessfully installed and the new hardware can be used remove the USB driver storage device from the PC Checking the Port USB port check only F...

Page 27: ...ons For safety the device requires regular maintenance To ensure functional and operational safety of TONOPORT VI Technical Safety Inspections should be carried out at least every 2 years The checks can be carried out by GE Healthcare within the framework of a service agreement please contact GE Healthcare Service for details The nature and scope of these checks are explained in the corresponding ...

Page 28: ...e between 25 and 100 If the displayed value is outside this range TONOPORT VI must be returned for repair Push again the display indicates 0 the display now indicates the pressure in mmHg Generate a test pressure of 200 mmHg and measure the pressure decrease after waiting at least 30 seconds Pressure decreases between 3 and 5 mmHg are typical a pressure decrease 6 mmHg indicates a leak and the sys...

Page 29: ...arge Time 2 to 3 hours Maximum Cuff Pressure 300 mmHg Measurement Method oscillometric selectable measurement method deflation measurement method or inflation measurement method Battery Charger protection class II IP20 100 to 240 VAC 50 60 Hz 0 5 A Ambient Conditions Operation temperature between 0 and 55 C relative humidity between 15 and 93 no condensation atmospheric pressure between 700 hPa an...

Page 30: ...nection cable TONOPORT VI to PC RS232 length approx 1 2 meters 2001589 211 TONOPORT BP Cuff for Adults Small for circumference between 17 and 26 cm Rectus connector 2001589 212 TONOPORT BP Cuff for Adults Standard for circumference between 24 and 32 cm Rectus connector 2001589 213 TONOPORT BP Cuff for Adults Large for circumference between 32 and 42 cm Rectus connector 2001589 214 TONOPORT BP Cuff...

Page 31: ...to verify normal operation in the configuration in which it is being used Guidance and Manufacturer s Declaration Electromagnetic Emissions TONOPORT VI is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to ensure that TONOPORT VI is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emis...

Page 32: ...pical commercial or hospital environment Surge to EN 61000 4 5 IEC 61000 4 5 0 5 kV differential mode 1 0 kV differential mode 0 5 kV common mode 1 0 kV common mode 2 0 kV common mode not applicable not applicable Mains power should be that of a typical commercial or hospital environment Voltage dips short inter ruptions and voltage varia tions on power supply input lines to EN 61000 4 11 IEC61000...

Page 33: ...d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in...

Page 34: ...output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 17 80 MHz to 800 MHz d 1 17 800 MHz to 2 7 GHz d 2 33 0 01 0 12 0 12 0 24 0 1 0 37 0 37 0 74 1 1 17 1 17 2 34 10 3 69 3 69 7 38 100 11 67 11 67 23 34 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using...

Page 35: ...ng The use of accessories transducers and cables other than those specified may result in increased emissions or decreased immunity performance of the equipment or system Note Any supplied accessories that would not affect electromagnetic compatibility EMC are not included 2001589 011 Connection cable TONOPORT VI to PC RS232 length of 1 2 meters 2001589 040 Connection cable TONOPORT VI to PC USB l...

Page 36: ...ce from the wearable pouch Please wear the pouch over your clothes You do not have to clean the device after the long term measurement Sometimes the device internally stops the long term measurement In this case deliver the device to the agreed date to your doctor The audio signals of the device are disabled by default If the doctor enables the audio signals the device will beep after power up pro...

Page 37: ...nflation measurement method 8 23 Inflation Measurement Technology 8 Information for patients 21 Intended Use 7 Interfacing with other equipment 9 M Maintenance 27 MDD 5 Measurement method 7 Measurement method select 17 Measurement protocol select 18 Memory clear 17 N Night and day phases toggling 23 Night phase 21 NiMH batteries charge 14 O Operating controls 11 Order information 30 P Patient info...

Page 38: ...Index 38 TONOPORT VI 2001589 312 Revision B U USB driver installation 26 W Warning 5 Weight 29 ...

Page 39: ......

Page 40: ...ical Systems Information Technologies Inc 9900 Innovation Drive Wauwatosa WI 53226 USA www gehealthcare com PAR Medizintechnik GmbH Co KG Sachsendamm 6 10829 Berlin Germany Tel 49 30 2350700 Fax 49 30 2138542 ...

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