TONOPORT V Operators Manual Rev C

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. © 2022 General Electric Company. All rights reserved.

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TONOPORT VI

2001589-312 Revision C

Contents

Table of Contents 1

Application, Safety 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

12

Patient Instructions

36

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Revision History

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

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.

2001589-312 Revision C

2022-07-08

Updated for MDR requirements of the TONOPORT VI device. Change of the Manufacturer’s address

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TONOPORT VI

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General Information

General Information  The product TONOPORT VI bears the CE marking

patient and operator safety. Please note that

CE 0482 (notified body MEDCERT GmbH)

information pertinent to several chapters is given

indicating its compliance with the provisions of the

only once. Therefore, carefully read the manual

Regulation (EU) 2017/745 (Medical Device

once in its entirety.

Regulation MDR) about medical devices and fulfills the essential requirements of Annex I of this

 The symbol

means: Follow the instructions

regulation. The devices have an internal power source

given in the operator manual. It indicates points

and are MDR class IIa devices. The devices fulfill the

which are important to avoid faulty measurements or

requirements of the Directive 2011/65/EU of the

injuries like strangulation of the arm.

European Parliament and of the Council and its

 This manual reflects the equipment specifications and

amending Directive (EU) 2015/863 of the European

applicable safety standards valid at the time of

Parliament and of the Council. The cuffs listed in

printing. All rights are reserved for devices, circuits,

Chapter 10 are a class I device and fulfill the General

techniques, software programs, and names appearing

Safety and Performance Requirements of Annex I of

in this manual.

the Regulation (EU) 2017/745 (Medical Device Regulation MDR). They are marked with the CE symbol

 On request GE Healthcare will provide a Field Service Manual.  The safety information given in this manual is

 It has a type BF applied part.

classified as follows:

 The product fulfills the requirements of the standard EN/IEC 60601-1 "Medical Electrical Equipment,

Danger

Part 1: General Requirements for Basic Safety and

indicates an imminent hazard. If not avoided, the

Essential Performance" as well as the electromagnetic

hazard will result in death or serious injury.

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 clinically validated. The validation

Warning indicates a hazard. If not avoided, the hazard can result in death or serious injury.

fulfills the standard ISO 81060-2:2013 " Noninvasive sphygmomanometers - Part 2: Clinical

Caution

investigation of automated measurement type" and

indicates a potential hazard. If not avoided, the haz-

the protocol ESH-IP 2010 from the European Society

ard may result in minor injury and/or product/prop-

of Hypertension.

erty damage.

 The radio-interference emitted by this product is within the limits specified in CISPR11/EN 55011,

operation and to guarantee the specified measuring

class B. 

 To ensure patient safety and interference-free

The TONOPORT VI recording unit, cuffs,

accuracy, we recommend using only original accessories available through GE Healthcare. The

and wearable pouch are certified by UL and thus fulfil

user is responsible for application of accessories from

the UL safety requirements.

other manufacturers.

 The CE marking covers only the accessories listed in

 Any serious incident occurring in relation to the device should be reported to the manufacturer and the

the "Order Information" chapter.  This manual is an integral part of the equipment. It should be available to the equipment operator at all

competent authority of the Member State in which the user and/or patient is established.

times. Close observance of the information given in the manual is a prerequisite for proper equipment performance and correct operation and ensures 2001589-312 Revision C

TONOPORT VI

5

General Information

PAR Medizintechnik GmbH & Co. KG Rigistr. 11 12277 Berlin Germany Tel. +49 30 235 07 00

GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226 USA The country of manufacture is indicated on the device label.

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Application, Safety Information

1

Application, Safety Information

1.1 Application

Using TONOPORT VI with CASE/CardioSoft

Intended Use

TONOPORT VI can be operated in conjunction

TONOPORT VI is intended to be used in combination

with CASE (version 6.73 or later) or with the

with a suitable blood pressure cuff for the automatic

analysis program CardioSoft (version 6.73 or later)

noninvasive measurement of the blood pressure (single

that is included with TONOPORT VI. If the USB

or 24-h-measurement of the systolic, diastolic and mean

port is used, it is necessary to install the appropriate

value), the heart rate and other vital or nonvital sign

driver first (see "Software Installation"). With these

parameters of human beings in the clinical daily routine.

systems, individual measurement protocols can be created and the stored data can be reviewed on

Indications

screen in tabular and graphic form. The patient ID

If the blood pressure cuffs listed in chapter "Order

used by the analysis program can be stored in

Information" fit the patient, it can be used on adults,

TONOPORT VI to allow the collected data to be

children, and small children.

downloaded without selecting the patient first (refer to the respective Operator Manuals).

TONOPORT VI is not suitable for blood pressure measurements in neonates. Also, it is not suitable for use in intensive care medicine. TONOPORT VI is intended for use following consultation and instruction by a

Biocompatibility The parts of the equipment described in this manual, including all accessories, that come in

physician.

contact with the patient during the intended use,

The device supports the physician in the diagnosis and

fulfill the biocompatibility requirements of the

supervision of pathophysiological blood pressures like

applicable standards if used as intended. If you

hypertension or hypotension. To establish a diagnosis the

have questions in this matter, please contact GE

measurement values should be combined with other

Healthcare or its representative.

measurements and physical examinations of the patient. TONOPORT VI can record up to 400 blood pressure measurements at selectable intervals and save the results.

The blood pressure is measured by the oscillometric method. The criteria for this method are the pressure

Note CASE / CardioSoft v6.73 supports only up to 200 memory readings.

Oscillometric Measurement Method

pulsations superimposed with every systole on the air pressure in the cuff. In order to measure the blood pressure, a blood pressure

There is a choice of three different measurement

cuff wrapped around the upper arm needs to be inflated

protocols.

and subsequently deflated. The blood pressure is determined either during 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 approx. 40 seconds (see Fig. 1-1).

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Application, Safety Information

Fig. 1-1 Waveform representing the pressure in the cuff during a measurement using the deflation measurement method: systolic pressure at 125 mmHg, diastolic pressure at 83 mmHg The inflation measurement method is a novel method

Fig. 1-2 Waveform representing the pressure in the cuff

based on the "Inflation Measurement Technology (IMT)"

during a measurement using the inflation

developed by PAR Medizintechnik. With this innovative

measurement method: systolic pressure at

technique, the cuff is inflated to a pressure just above the

125 mmHg, diastolic pressure at 83 mmHg

expected systolic value. Once the systolic value is determined, the cuff can immediately and quickly be deflated. The measurement typically takes only approx. 20 seconds (see Fig. 1-2).

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

If disturbances occur during measurements with the

hydrostatic pressure of the liquid column in the blood

inflation measurement method, which may be due to

vessels will lead to incorrect results.

motion artifacts, for example, TONOPORT VI will

When the patient is sitting, lying, or standing during

automatically switch to the deflation measurement method and complete the blood pressure measurement.

measurements, the cuff is automatically at the correct level.

1.2 Functional Description The TONOPORT VI monitor accommodates the blood pressure measuring system and a microprocessor for system control and data processing. A second microprocessor with a second pressure transducer and a second valve are provided for control of the technical safety. The monitor is powered by two AA size batteries (either rechargeable NiMH batteries or alkaline batteries).

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Application, Safety Information

1.3 Safety Information Danger

Warning

Risk to Persons- – The equipment is not designed for use in areas

Risk to Persons- – Equipment may be connected to other equipment

where an explosion hazard may occur. Explosion

or to parts of systems only when it has been made

hazards may result from the use of flammable

certain that there is no danger to the patient, the

anesthetic mixtures with air or with oxygen,

operators, or the environment as a result. In those

nitrous oxide (N2O), skin cleansing agents, or

instances where there is any element of doubt

disinfectants.

concerning the safety of connected equipment, the user must contact the manufacturers concerned or other informed experts as to whether there is any possible danger to the patient, the operator, or the environment as a result of the proposed combination of equipment. Compliance with the standard IEC 60601-1 or IEC 60950-1 must always be ensured. – Connection 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 of additional items (e.g. connecting another TONOPORT device to another port of the PC can lead to interference during data transfer) • disconnection of items • update or upgrade of equipment – TONOPORT VI may be connected to CASE or to a PC with the CardioSoft program. While connected to any of these devices, TONOPORT VI must be disconnected from the patient. – Chemicals required, for example, for the maintenance of the equipment must under all circumstances be prepared, stored, and kept at hand in their specific containers. Failure to observe this instruction may have severe consequences.

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Application, Safety Information

Warning

Caution

Risk to Persons- – The equipment has no protection against the

Equipment damage, risk to persons- – Before connecting the battery charger to the power

ingress of liquids. Liquids must not enter the

line, check that the voltage ratings on the

equipment. Equipment into which liquids have

nameplate match those of your local power line.

entered must be inspected by a service technician

– The battery charger is not a medical device. Its use

before use.

in the patient environment is not permitted.

– Before cleaning, TONOPORT VI must be disconnected from other equipment (CASE, PC).

– Before using the equipment, the operator must ascertain that it is in correct working order and

– Dispose of the packaging material, observing the applicable waste-control regulations. Keep the

operating condition. – The operator must be trained in the use of the

packaging material out of children's reach.

equipment. – Only persons who are trained in the use of medical

Incorrect measurements-

technical equipment and are capable of applying it

– Magnetic and electrical fields are capable of

properly are authorized to apply such equipment.

interfering with the proper performance of the

– There are no user-replaceable components inside

equipment. For this reason make sure that

the equipment. Do not open the housing. For

external equipment operated in the vicinity of TONOPORT VI complies with the relevant EMC requirements. X-ray equipment, MRI devices,

service or repair, please contact your local, authorized dealer (http://gehealthcare.com).

radio systems etc. are possible sources of interference as they may emit higher levels of electromagnetic radiation.

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2001589-312 Revision C

Controls and Indicators

2

Controls and Indicators 1

Functions of Button 2

Button

INFO

Message Function

INFO

on display

3

4

Push once

H1

clear memory

Push twice

H2

set date and time

Push 3 times

H3

select measurement protocol

Push 4 times

H4

activate calibration mode

Push 5 times

H5

display firmware version

Push 6 times

H6

select energy source

Push 7 times

H7

enable/disable audio signal

Push 8 times

H8

toggle pressure unit between mmHg and kPa

5

Push 9 times

H9

select measurement method: deflation measurement method or inflation measurement method

1

Button

INFO

: push to display the most recent

parameter readings. The display will show: – systolic value "S" (unit mmHg or kPa shown on the display) – diastolic value "D" (unit mmHg or kPa shown on the display) – pulse rate "HR" (unit min-1)

6 7

The same button is used – to toggle between the day phase and the night phase (section "Toggling Between Day and Night

8

Phase") and – to program the BP monitor (chapter 3 "Setup")

9 10

2

Connection for blood pressure cuff

3

Calibration mark

4

Liquid crystal display (LCD)

5

Button

START STOP

: push to start and stop a measure-

ment and to confirm entries

Fig. 2-1 Controls and indicators of TONOPORT VI

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6

(Rechargeable) batteries

7

Lid covering battery compartment

8

Nameplate

9

Port for connection to PC (RS232)

10

Port for connection to PC (USB)

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11

Controls and Indicators

Explanation of Signs and Symbols Symbols used on the equipment and on the packaging Follow the instructions given in the operator manual. This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

IP20

Protection against ingress of solid foreign objects and no protection against ingress of water.

IP02

No protection against contact and ingress of objects and protection against dripping water when tilted at 15°.

Type BF applied part (defibrillationproof, recovery time tR < 1 s)

Keep dry

Temperature limits

Article number (Manufacturer) Humidity limits Serial number Air pressure limits

Lot number Order No.

UDI-DI

0482

Order Number (Distributor) USB port, connection to PC

UDI-DI number Medical device

Serial port, connection to PC

CE marked per the Council Regulation (EU) 2017/745 of the European Union. Notified body: MEDCERT GmbH.

Manufacturer’s identification Date of manufacture. The number found under this symbol is the date of manufacture in the YYYYMM format.

Gossudarstwenny Standart Russia (GOST) Eurasian Conformity mark. Conformity to applicable technical regulations of Customs Union.

Distributor‘s identification

MEDICAL - PATIENTMONITORING 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)

Ambulatory Blood Pressure Measurement Device Calibration mark, valid in Germany only (see "Technical Inspections of the Measuring System")

Caution: Federal law restricts this device to sale by or on the order of a physician.

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Setup

3

Symbols used on the display

M

Blinks with each detected oscillation; is continuously displayed when the monitor contains data.

Setup

Some Basic Facts on Battery Power TONOPORT VI is either powered by two rechargeable nickel-metal hydride batteries (NiMH) or by two alkaline

Blinks when the batteries are almost depleted; is continuously displayed when batteries are discharged and no more BP measurements can be taken.

batteries. The device must be set to the power source used

Day phase selected

The capacity of two fully charged or new batteries is

(see section "Inserting Batteries"). The device also contains a Lithium cell that powers the clock. The Lithium cell can only be replaced by a service technician.

sufficient for up to 400 blood pressure measurements. Night phase selected

The capacity of rechargeable batteries decreases with age. If the capacity of fully charged batteries is

Further relevant symbols used on the battery charger

considerably less than 24 hours, the batteries must be replaced.

+

Polarity of the DC input (charger only)

xxx-xx xxxx

Approval mark for use of the equipment in a vehicle (charger only, xxx-xx xxxx alphanumeric characters)

E4

Caution Equipment Damage- – Only use the original rechargeable, size AA nickelmetal hydride batteries (from manufacturers such as Sanyo, Panasonic, Energizer, Duracell, Varta, GP) with a capacity > 1500 mAh or high-rate

Protection class II equipment

discharge, size AA alkaline batteries (such as Panasonic Evoia, Energizer Ultimate, Duracell Ultra, Duracell Power Pix, Varta maxtech).

For indoor use only

– Charge the NiMH batteries to capacity before using them for the first time.

PS E

– Recharge the NiMH batteries immediately after

Approval mark for Japan

use and do not leave batteries uncharged. – Use only the original charger to recharge the NiMH batteries.

China RoHS pollution control label

RoHS

– Do not attempt to recharge alkaline batteries.

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.

2001589-312 Revision C

– If TONOPORT VI will not be used for one month or more, remove the (rechargeable) batteries from the device. – Batteries must not be disposed as unsorted

TONOPORT VI

municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of the batteries.

13

Setup

Inserting Batteries

Charging NiMH Batteries

 Open the battery compartment on the back of

Caution

TONOPORT VI as shown in Fig. 3-1.

Equipment damage, patient hazard - – The battery charger is not a medical device. Its use in the patient environment is not permitted. – The contact surface of the NiMH batteries and of the charger must always be kept clean. – The charger is to be used indoors only and must be protected against oil, grease, aggressive detergents and solvents to prevent damage. – If the charger is damaged in any way, e.g., after a drop or when the mains pins are bent, the local authorized dealer must be contacted immediately.

Fig. 3-1 Opening the battery compartment

– High temperatures affect the charging process. Ideally, the room temperature should not exceed

 Place the two batteries in the compartment as

40°C.

indicated by the symbols.

– After quick charging, please wait for some minutes

Selecting the Energy Source

before another quick charge. Otherwise the temperature sensors will not function correctly.

 Turn on the BP monitor as follows: either by inserting the batteries or by briefly pressing

If TONOPORT VI is powered by rechargeable batteries

the START button. STOP

(4 of them are shipped with the equipment), they should

 Wait for the time to be displayed.  Push

INFO

be recharged immediately after use (24 hours). Use only the original charger supplied. It consists of an AC power

six times: The display shows "H 6".

 Push START : the display shows "AAAA" when the BP STOP

adapter and the charging unit itself.

monitor is set up for rechargeable NiMH batteries (as shipped) and "bbbb" when it is set up for alkaline batteries.  Confirm the displayed information with START or STOP change the selection with selection with

START STOP

INFO

and confirm the new

.

 Next, the BP monitor will briefly display the capacity of the inserted batteries. "A 100", for instance, means that the rechargeable batteries 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.  Place the lid on the battery compartment and close. Note The energy source needs to be selected only when the BP monitor is put into service for the first time or when you change from NiMH to alkaline batteries and vice versa. 14

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Setup

Charging Batteries with the VARTA Charging Unit

Fig. 3-2 Exchanging the connector, connecting the charging unit

display

 Check that the voltage ratings on the nameplate of the charging unit match those of your local power line.  If necessary, replace the connector to match the wall outlet type: – push the button below the connector and hold it depressed (1, Fig. 3-2) – remove the connector and insert the suitable type of connector 2, 3 – ensure that the new connector locks into place.  Connect the cable of the AC power adapter to the charging unit 4 and plug the AC power adapter into the wall outlet.

Insert 4 or 2 batteries. To charge only 2 batteries, insert them in the two compartments 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 inserted or the batteries are inserted the wrong way round. When the batteries are charged, the bars are permanently illuminated. The charging unit now trickle-charges the

 Insert the two rechargeable batteries into the charging unit, observing the correct polarity.

Fig. 3-3 Battery symbols and bars in the charging unit

batteries to compensate for self-discharging. The battery temperature is monitored in the charger. When the temperature is too high, the bar in the battery symbol is permanently illuminated and the charger switches to trickle-charging. If the batteries are correctly inserted and the displayed battery symbols show no bars, the charger has identified a battery problem. The charging current will be cut off. Remove the batteries and discard, observing the applicable waste disposal regulations.

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Setup

Switching TONOPORT VI ON and OFF The TONOPORT VI monitor has no power switch. Switch the device on and off as follows: To switch ON:

Insert charged batteries OR briefly press START . STOP

To switch OFF: Press START for 3 seconds. STOP

Performance Check When turned on, TONOPORT VI runs a self-test that includes all symbols and segments on the LCD (Fig. 3-4). Then it checks the batteries and indicates the remaining capacity. "A 100", for instance, means that the rechargeable batteries 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

Fig. 3-4 Test display on LCD

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 time of day – the measuring phase (day

/ night

), and

– whether data are stored in the BP monitor (M) (Fig. 35). The BP monitor will also emit an audio signal if enabled.

Fig. 3-5 Example: display after successful self-test (M= BP data in memory,

measuring phase:

day)

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Setup

Before using TONOPORT VI on a patient

Selecting the Measurement Method

1.

clear the memory

 Briefly switch TONOPORT VI off and on again and

2.

check date and time and adjust if required

3.

select a measurement protocol

4.

enable or disable the audio signal.

wait for the time to be displayed.  Push

INFO

9 times: the display indicates "H 9".

 Push START : the display indicates "0000" if the STOP

Note When using TONOPORT VI in conjunction with CASE/CardioSoft, it is recommended to perform the first three steps at the PC.

selected method is the deflation measurement method, or "1111" if the selected method is the inflation measurement method.  Either confirm with tion with

INFO

START STOP

or switch to the other op-

, then confirm with

START STOP

.

Clearing the Memory The symbol M on the display indicates that the memory holds BP data. If these data still need to be analyzed, refer to chapter 5 "Data Output" for details on data evaluation. If you do not need the data any more, delete it as follows:  Briefly switch TONOPORT VI off and on again and wait for the time to be displayed.  Push

INFO

: the display indicates "H 1".

 Push START : the display indicates "LLLL". STOP  To delete the data, push START again: the display STOP indicates "0000", followed by the time (if you do not wish to clear the memory, turn off the BP monitor instead of pushing START ). STOP

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Setup

Time and Date

Measurement Protocols

Usually the BP monitors are set to the correct time and

There is a choice of three different measurement

date before delivery. Therefore, the time only needs to be

protocols:

corrected to change between Standard Time and Daylight Protocol

Saving Time.

Day Phase

Night Phase

(7 a.m. to 10 p.m.) (10 p.m. to 7 a.m.) Setting Time and Date

P1

every 15 minutes

every 30 minutes

 Briefly switch TONOPORT VI off and on again and

P2

every 20 minutes

every 40 minutes

P3

every 30 minutes

every 60 minutes

wait for the time to be displayed. INFO

 Push

twice: the display indicates "H 2".

 Push START : The year will be displayed, e.g. "2020". STOP

Max. inflation pressure:

day phase 250 mmHg night phase 220 mmHg

 If the indicated year is correct, confirm it with START STOP or correct it with

INFO

, then confirm with START . STOP

 The month will be displayed, e.g. "03".

 Briefly switch TONOPORT VI off and on again and

 If the indicated month is correct, confirm it with START STOP START STOP

or correct it with

INFO

Selecting a Measurement Protocol

, then confirm with

wait for the time to be displayed.  Push

INFO

3 times: the display indicates "H 3".

 Push START : the display indicates "LLLL" (Selecting STOP

.

a protocol automatically clears the memory. If you

 In the same manner, correct day, hour, and minute.

want to retain the data, switch the BP monitor off.)

 In the end, the time of day will be displayed again.

 Push START : the display indicates "P1" (protocol 1). STOP  Either select program 2 or 3 by pushing

Selecting the Pressure Unit  Briefly switch TONOPORT VI off and on again and

INFO

or

 confirm the selected protocol with START . STOP

wait for the time to be displayed.  Push

INFO

 Push

START STOP

8 times: the display indicates "H 8".

Enabling or Disabling the Audio Signal

: the display indicates "mmHg" or "kPa".

 Either confirm with option with

INFO

START STOP

or switch to the other

, then confirm with START . STOP

 Briefly switch TONOPORT VI off and on again and wait for the time to be displayed.  Push

INFO

7 times: the display indicates "H 7".

 Push START : the display indicates "0000" when the STOP audio signal is disabled, and "1111" when it is enabled.  Either confirm with START or switch to the other STOP option with

18

TONOPORT VI

INFO

, then confirm with START . STOP

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Application

4

Application

Symbols used on the cuff

Cleaning the Cuffs – The single-use cuffs may not be reused. Therefore,

Follow the instructions given in the

these cuffs need not to be cleaned.

operator manual. Caution Blood pressure cuff fits adult

Used single-use-cuffs may be contaminated

patient of the size marked by the

and /or damaged.

frame (Standard, Small, Large, or Extra-large).

– Use a moist cloth to wipe the cuffs clean if they are only slightly soiled.

Blood pressure cuff is suitable for

– Clean cuffs that are heavily contaminated by washing

the indicated arm circumference.

them with soapy water or a suitable cleaning agent

When the blood pressure cuff is applied, this label must face the skin (single-use cuff).

that contains a disinfectant (do not machine-wash). Ensure that no liquid penetrates into the cuff bladder or the pressure tubing. – After cleaning, rinse the cuff thoroughly with water

When the blood pressure cuff is applied, this arrow must be located over the brachial or femoral artery.

and let it dry at room temperature for about 15 hours. – The cuffs can be disinfected with isopropyl alcohol 70%, ethanol 70%, mikrozid universal liquid, Buraton rapid, Sporicidin, or Cidex. After disinfection, rinse the cuff thoroughly with tap water and air-dry.

This line identifies the end of the cuff which must be situated within the range identified by the 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.

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Application

Applying the Cuff Warning Risk to Persons- Disconnect TONOPORT VI from other equipment (CASE, PC) before connecting it to the patient.  Always insert 2 fully charged NiMH batteries or two new alkaline batteries, before starting a measurement.  Check that the memory has been cleared (see "Clearing the Memory").  Select the appropriate cuff size (see cuff label). When the cuff is too small the BP values will be overrated, when it is too big, the measured values

Fig. 4-1 Applying the cuff

will be too low. Caution Incorrect measurements- – Use only the cuffs listed in chapter "Order Information". – Replace cuffs on a regular basis. Damaged Velcro fasteners may cause incorrect readings. Index

– When using a small cuff, only the deflation measurement method should be used (see chapter "General Information on Ambulatory BP Measurement").

Index

Index

 Place the cuff on that arm of the patient which is used less frequently during normal daily activities: on adults about 2 fingers' breadth above the bend of the

Fig. 4-2 Applying the cuff

elbow, on children a little closer. Bending the arm must not change the cuff level. Verify that – the cuff tubing points up toward the shoulder (Fig.

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.

4-1) – no compression or restriction of connection tubing can occur – the side with the

label is on the skin (sin-

gle-use cuffs)

– Too frequent measurements can cause injury to the patient due to blood flow interference.

– the arrow is located above the brachial or femoral

– The application of the cuff over a wound can cause further injury.

– the dashed white line at the end of the cuff is

– The application of the cuff and its pressurization on the arm on the side of a mastectomy is not recommended.

when you close the cuff (if this is not the case,

– The pressurization of the cuff can temporarily cause loss of function of simultaneously used monitoring equipment on the same limb.

artery located between the two dashed

lines

select another cuff size, Fig. 4-2) – the cuff fits snugly around the arm, but does not compress the blood vessels

– By watching the limb it is necessary to check that operation of the TONOPORT VI does not result in prolonged impairment of patient blood circulation.

– the cuff and the TONOPORT VI are used inside the ambient conditions for operation and inside the measuring range (see chapter "Technical Specifications").

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TONOPORT VI

2001589-312 Revision C