TONOPORT V Operators Manual Firmware Ver 2.1 Rev F July 2016

Note The information in this manual only applies to TONOPORT V, firmware version 2.1. 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. © 2009–2016 General Electric Company. All rights reserved.

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TONOPORT V

2001589-085 Revision F

Contents

1

Application, Safety Information

6

2

Controls and Indicators

10

3

Setup

12

4

Application

17

5

Data Output

21

6

Error Codes

22

7

Software Installation

23

8

Cleaning, Maintenance, Disposal

25

9

Technical Specifications

27

10

Order Information

28

11

Appendix - Electromagnetic Compatibility (EMC)

29

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

2001589-085 Revision A

2009-05

Initial release

2001589-085 Revision B

2010-04

General Information: modifications in 3rd paragraph Section 1.3: additional information concerning the ingress of liquids Chapter 2: four symbols added Chapter 3: additional information concerning alternative charger

2001589-085 Revision C

2011-10-31

CardioSys was removed globally Chapters 1.1, 5 and 7: interface restrictions for CASE/CardioSoft were added Chapter 2: relevant battery charger symbols were added Chapter 7: CardioSoft version 6.7 for Windows 7 and reference to the “CASE-CS” folder were added Chapter 9: measuring range for mean pressure was corrected to '50 to 250 mmHg'

2001589-085 Revision D

2014-01-31

Changes on pages 4, 5, 11, 12, 23, and 24.

2001589-085 Revision E

2015-05-07

Changes on pages 8, 17, and 27.

2001589-085 Revision F

2016-07-12

Changes on pages 4, 11, and 28.

2001589-085 Revision F

TONOPORT V

3

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. All rights are reserved for devices, circuits,

Council Directive 93/42/EEC about medical devices

techniques, software programs, and names appearing

(including amendment 2007/47/EC) and fulfills the

in this manual.

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 of the European Parliament and of the Council.

 On request GE Healthcare will provide a detailed Service Manual.  The safety information given in this manual is classified as follows:

 It has a type BF applied part.

Danger

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

indicates an imminent hazard. If not avoided, the hazard will result in death or serious injury.

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 –

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

Requirements and tests" and applicable amendments. Caution

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

indicates a potential hazard. If not avoided, the

class B.

hazard may result in minor injury and/or product/

 The CE marking covers only the accessories listed in

property damage.

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

 To ensure patient safety and interference-free operation and to guarantee the specified measuring accuracy, we recommend only original equipment accessories as available through GE Healthcare distribution. The user is responsible for the application of accessories from other manufacturers.

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: Consult accompanying

documents. It indicates points which are of particular importance in the operation of the equipment.

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TONOPORT V

2001589-085 Revision F

General Information

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

Distributor: GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA Tel:

+1 414 355 5000 1 800 437 1171 (USA only) 1 800 668 0732 (Canada only)

Fax:

+1 414 355 3790

The country of manufacture appears on the device label.

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5

Application, Safety Information

1

Application, Safety Information

1.1 Application Biocompatibility

Intended Use

The parts of the equipment described in this

TONOPORT V is a small-size, patient-borne blood

manual, including all accessories, that come in

pressure monitor for ambulatory, non-invasive

contact with the patient during the intended use,

measurement of the patient’s blood pressure. If the blood

fulfill the biocompatibility requirements of the

pressure cuffs listed in chapter 10 "Order Information" fit

applicable standards if used as intended. If you

the patient, it can be used on adults, children, and small

have questions in this matter, please contact GE

children. TONOPORT V is not suitable for blood

Healthcare or its representatives.

pressure measurements in neonates. 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 patient's blood pressure at selectable intervals and saves the results. There is a choice of three different measurement protocols.

The blood pressure is measured by the oscillometric method. The criteria for this method are the pressure pulsations superimposed with every systole on the air pressure in the cuff.

Using TONOPORT V with CASE™ / CardioSoft TONOPORT V can be operated in conjunction with CASE™ (version 5.15 or later) or with the analysis program CardioSoft (version 4.14 or later) that is included with TONOPORT V. If the USB port is used (CardioSoft only), it is necessary to install the appropriate driver first (see “Software Installation” on page 23). With these systems, individual measurement protocols can be created and the

The blood pressure cuff is wrapped around the upper arm and inflated to a pressure which must be clearly above the expected systolic pressure. A pressure transducer measures the cuff pressure as well as the superimposed pressure pulsations. During blood pressure measurements the cuff must be level with the heart. If this is not ensured, the hydrostatic pressure of the liquid column in the blood vessels will lead to incorrect results.  When the patient is sitting or standing during

stored data can be reviewed on-screen in tabular

measurements, the cuff is automatically at the correct

and graphic form. With V6.5 and subsequent

level.

versions, the patient ID used by the analysis program can be stored in TONOPORT V to allow the collected data to be downloaded without selecting the patient first (refer to the respective Operator Manuals; you will find the CardioSoft manual on the CardioSoft CD).

Fig. 1-1 Waveform representing the pressure decrease in the cuff during a measurement: systolic pressure at 131 mmHg, diastolic pressure at 76 mmHg

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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).

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Application, Safety Information

1.3 Safety Information Warning

Danger

Risk to persons - – Equipment may be connected to other

Risk to persons - – The equipment is not designed for use in areas where an explosion hazard may occur. Explosion

equipment or to parts of systems only when it

hazards may result from the use of flammable

has been made certain that there is no danger to

anesthetic mixtures with air or with oxygen,

the patient, the operator, or the environment as

nitrous oxide, skin cleansing agents or

a result. In those instances where there is any

disinfectants.

element of doubt 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 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. – Chemicals required for the maintenance of the equipment, for instance, must under all circumstances be prepared, stored, and kept at hand in their specific containers. Failure to observe this instruction may have severe consequences for the patient. – The equipment has no protection against the ingress of liquids. Liquids must not enter the equipment. Equipment into which liquids have entered must be inspected by a service technician before use. – Before cleaning, TONOPORT V must be disconnected from other equipment (CASE™, PC). – Dispose of the packaging material, observing the applicable waste-control regulations. Keep the packaging material out of children's reach.

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Application, Safety Information

Warning

Caution

Incorrect measurements -

Equipment damage, risk to persons -

– Magnetic and electrical fields are capable of

– Before connecting the battery charger to the

interfering with the proper performance of the

power line, check that the voltage ratings on the

equipment. For this reason make sure that

nameplate match those of your local power line.

external equipment operated in the vicinity of

– 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, radio systems, etc. are possible sources of

– Before using the equipment, the operator is required to ascertain that it is in correct working

interference as they may emit higher levels of electromagnetic radiation.

order and operating condition. – The operator must be trained in the use of the equipment. – Only persons who are trained in the use of medical technical equipment and are capable of applying it properly are authorized to apply such equipment. – There are no user-replaceable components inside the equipment. Do not open. For service or repair, please contact your local, authorized dealer (http://gehealthcare.com).

2001589-085 Revision F

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9

Controls and Indicators

2

Controls and Indicators

1

Connection for blood pressure cuff

2

Button

INFO

: push to display the most recent

parameter readings. Readings appear in the

1

following order:

3

- systolic value "S" (unit mmHg or kPa shown on the display)

2

- diastolic value "D" (unit mmHg or kPa shown on P

B N

the display)

4

S ST TART OP

IN

- pulse rate "HR" (unit min-1)

FO

The same button is used - to toggle between the day phase and the night

TO O N

11

O P S

T R

D -1

in /m R H

V

phase chapter 4, section "Toggle Manually Between Day and Night Phase") and

10

- to program the BP monitor (chapter 3 "Setup") !

off

9

5

0 on

3

Button START : push to start and stop a STOP measurement, and to confirm entries

I

6 4

Liquid crystal display (LCD)

5

Port for connection to PC (USB)

6

Port for connection to PC (RS232)

7

Calibration mark

8

Lid covering battery compartment

9

(Rechargeable) batteries

Fig. 2-1 TONOPORT V controls and indicators

10

ON/OFF switch

Functions of the

11

Nameplate

7

8

Button

INFO

INFO

Button Function

Message on display

Push once

H1

clear memory

Push twice

H2

set date and time

Push 3 times

H3

select the 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

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2001589-085 Revision F

Controls and Indicators

Explanation of Signs and Symbols For indoor use only

Symbols used on the equipment and on the packaging

Caution, consult accompanying documents

Manufacturer’s identification

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.

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

Type BF applied part (defibrillation-proof)

Calibration mark, valid in Germany only (see section "Technical Inspections of the Measuring System" in chapter 8)

Symbols used on the display M

Catalogue number Serial number

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

CE marking CE marked per the Medical Device 0482 Directive 93/42/EEC of the European Union. The notified body is MEDCERT GmbH. Gossudarstwenny Standart Russia (GOST)

blinks with each detected oscillation; is continuously lit when the monitor contains data

day phase selected night phase selected Further relevant symbols used on the battery charger

In the USA, the product is only for use by or on the order of a physician, or persons licensed by U.S. law.

TR15RA120 100-240V 0.4A 47-63Hz 12V 1.1A

USB port, connection to PC

Power supply type designation and ratings

UL-certified product

Serial port, connection to PC Approval mark for Japan Polarity of the DC input (charger only) Approval mark for use of the equipment in a vehicle (charger only, xxx-xx xxxx alphanumeric characters)

Pollution control symbol according to the Chinese standard SJ/T113632006

Class II equipment

For indoor use only

2001589-085 Revision F

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11

Setup

3

Setup

Some Basic Facts on Battery Power

 Hold TONOPORT V as shown in Fig. 3-1 and slide

TONOPORT V is either powered by two rechargeable Nickel Metal Hydrid batteries (NiMH) or by two alkaline

the lid of the battery compartment open (approx. 1 cm).

batteries. The device must be set to the power source used (see section "Insert Batteries" below). The device also contains a Lithium cell that powers the clock. The Lithium cell can only be replaced by a service technician. The capacity of two fully charged or new batteries is sufficient for a minimum of 30 hours of operation or for 200 measurements. The capacity of rechargeable batteries decreases with age. If the capacity of fully charged batteries is considerably less than 24 hours, the batteries must be replaced. Caution Equipment damage - – Only use the original rechargeable, size AA Nickel

Fig. 3-1 Opening the battery compartment

Metal Hydrid batteries (from manufacturers such

It is not possible to open the lid more than about 1 cm

as Sanyo, Panasonic, Energizer, Duracell, Varta,

which is just enough to reach the ON/OFF switch. To

or GP) with a capacity > 1500 mAh or size AA

replace batteries, you must take off the lid (pull upward).

high-rate discharge alkaline batteries (such as Panasonic Evoia, Energizer Ultimate, Duracell Ultra, Duracell Power Pix, or Varta maxtech). – Charge the NiMH batteries to capacity before

 Place the two batteries in the compartment as indicated by the symbols.

Select Energy Source

using them for the first time. – Recharge the NiMH batteries immediately after use and do not leave batteries uncharged. – Use only the original charging unit to recharge the NiMH batteries. – Do not attempt to recharge the alkaline batteries.

 Turn on the BP monitor. The switch is located inside the battery compartment. Slide the switch to the right, while looking at the display.  Wait for the time to be displayed.  Push

– If the TONOPORT V will not be used for one

INFO START STOP

six times: the display shows "H 6".

month or more, remove the (rechargeable) INFO

 Push START : the display will show "AAAA" when the STOP

batteries from the device. – Batteries must not be disposed as unsorted

BP monitor is set up for rechargeable NiMH batteries

municipal waste and must be collected separately.

(as shipped) and "bbbb" when it is set up for alkaline

Please contact an authorized representative of the

batteries.

manufacturer for information concerning the

INFO

 Confirm the displayed information with START STOP or

decommissioning of the batteries.

INFO

change the selection with START STOP and confirm the new

Insert Batteries

selection with Note batteries. To do so, slide the ON/OFF switch (10,

12

.

 Next the BP monitor will briefly display the capacity

Switch TONOPORT V off before inserting the Fig. 2-1) to the left while looking at the display.

INFO START STOP

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

TONOPORT V

2001589-085 Revision F

Setup

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

1

The energy source needs to be selected only when

4

the BP monitor is put into service for the first time

3

or when you change from NiMH to alkaline

2

batteries and vice versa. COMPIT

TC 4

Charge NiMH Batteries Caution Equipment damage, risk to patients - – The charger is not a medical device. It must not be used in the patient environment. – The contact surface of the NiMH batteries and

Fig. 3-2 Exchanging the connector, connecting the charger

of the charger must always be kept clean. – The charger is to be used indoors only and must

 If necessary, replace the connector to match the wall

be protected against oil, grease, aggressive

outlet type:

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. – High temperatures affect the charging process. Ideally, the room temperature should not exceed 40 °C (104 °F).

– 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

– After quick charging, please wait for some

the wall outlet.

minutes before another quick charge.

 Insert the two batteries into the charging unit, observ-

Otherwise the temperature sensors will not

ing the correct polarity.

function correctly. If TONOPORT V 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

Two different charger models are available:  COMPIT TC4  VARTA

adapter and the charging unit itself.  Check that the voltage ratings on the nameplate of the charging unit match those of your local power line.

2001589-085 Revision F

TONOPORT V

13

Setup

Charge Batteries with the COMPIT TC4 Charger

Charge Batteries with the VARTA Charger

COMPIT

TC 4

Fig. 3-3 Red LEDs on charger

Fig. 3-4 Battery symbols and bars in the charger display

The batteries take up to 3 hours to recharge. Each of the

Insert 4 or 2 batteries. To charge only 2 batteries, insert

red LEDs corresponds to one of the charger

them in the two compartments on the right or on the left.

compartments (Fig. 3-3). During the charge cycle, the

The batteries take up to 3 hours to recharge. Once the

corresponding red LED blinks at a slow rate

batteries are inserted, battery symbols will appear in the

(approximately once per second). Note: If the red LED

charger display where each symbol corresponds to one of

does not light up, the battery may be inserted the wrong

the charger compartments (Fig. 3-4). During the charge

way round. When the battery is charged, the LED is solid

cycle, the corresponding bar in the battery symbols

red. The charging unit now trickle-charges the battery to

blinks. Note: If the battery symbols and bar do not light

compensate for self-discharging.

up, only one battery may be inserted or the batteries are

The battery temperature is monitored in the charger. When the temperature is too high, the LED is solid red and the charger switches to trickle-charging.

charged, the bars are permanently illuminated. The charging unit now trickle-charges the battery to compensate for self-discharging.

If the battery is correctly inserted and the red LED does not light up, 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.

inserted the wrong way round. When the batteries are

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 to the compartment concerned will be cut off. Remove the battery and discard, observing the applicable wastedisposal regulations.

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Setup

Performance Check When turned on, TONOPORT V runs a self-test that

Note

includes all symbols and segments on the LCD (Fig. 3-5).

When using TONOPORT V in conjunction with

Then it checks the batteries and indicates the remaining

CASE™ / CardioSoft, it is recommended to

capacity. "A 100", for instance, means that the

perform the first three steps at the PC.

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.

Clear the Memory The symbol M on the display indicates that memory

The minimum battery capacity for a 24-hour

contains BP data. If these data still need to be analyzed,

measurement is 90%.

refer to chapter 5 "Data Output" for details on data

If the capacity is below 90%, new or fully charged

evaluation. If you do not need the data any more, delete it

batteries must be inserted.

as follows:

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: – the time of day – the measuring phase (day

/ night

)

– whether or not data are stored in the BP monitor (M)

wait for the time to be displayed.  Push

INFO START STOP

: the display indicates "H 1".

 Push

INFO START STOP

: the display indicates "LLLL".

(Fig. 3-6). The BP monitor will also emit an audio signal, if enabled.

INFO  To delete the data, push START again: the display indiSTOP

cates "0000", followed by the time (if you do not wish to clear the memory, turn off the BP monitor instead INFO of pushing START ). STOP

M

kPa

mmHg

Fig. 3-5 Test display on LCD

M Fig. 3-6 Example: display after successful self-test (M= BP data in memory, measuring phase: day) Before using TONOPORT V on a patient 1.

clear the memory

2.

check date and time and correct, if required

3.

select a measurement protocol

4.

enable or disable the audio signal.

2001589-085 Revision F

TONOPORT V

15

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.)

P1

every 15 minutes

every 30 minutes

P2

every 20 minutes

every 40 minutes

P3

every 30 minutes

every 60 minutes

Setting Date and Time  Briefly switch TONOPORT V off and on again and wait for the time to be displayed. INFO

 Push START twice: the display indicates "H 2". STOP

Max. inflation pressure: day phase 250 mmHg night phase 220 mmHg

INFO

 Push START : the display indicates the year, e.g. STOP "2009". INFO

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

INFO START or correct it with START STOP and confirm with STOP .

Select a Measurement Protocol  Briefly switch TONOPORT V off and on again and wait for the time to be displayed.

– The display indicates the month, e.g. "03". INFO

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

INFO

 Push START STOP three times: the display indicates "H 3". INFO  Push START : the display indicates "LLLL" (Selecting STOP

INFO

or correct it with START and confirm with START . STOP STOP

a protocol automatically clears the memory. If you do

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

not wish to clear the memory, turn the BP monitor

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

off.)

Selecting the Pressure Unit  Briefly switch TONOPORT V off and on again and wait for the time to be displayed.

INFO  Push START : the display indicates "P1" (protocol 1). STOP

INFO

 Using START , select protocol 2 or 3 STOP

INFO

 Push START eight times: the display indicates "H 8". STOP INFO

 Push START : the display indicates "mmHg" or "kPa". STOP

OR INFO

 Confirm the displayed protocol with START STOP .

INFO

 Confirm the pressure unit with START or select the othSTOP

Enable or Disable the Audio Signal

INFO

INFO START er unit with START STOP , then confirm with STOP .

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

 Push START seven times: the display indicates "H 7". STOP INFO  Push START : the display indicates "0000" when the auSTOP

dio signal is turned off, and "1111" when it is turned on. INFO

INFO

 Either confirm the setting with START or press START to STOP STOP INFO

select the alternate setting and confirm with START . STOP

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2001589-085 Revision F

Application

4

Application

Symbols used on the cuff

Cleaning the Cuffs – Use a moist cloth to wipe the cuffs clean if they are

Refer to Operator Manual.

only slightly soiled. – Clean cuffs that are heavily contaminated by washing them with soapy water or a suitable cleaning agent

Follow the instructions in the

that contains a disinfectant (do not machine-wash).

Operator Manual.

Ensure that no liquid penetrates into the cuff bladder

Cuff suitable for adult patients of

or the pressure tubing (for this reason, remove the

the indicated height (see man in

bladder from the cuff before cleaning).

box). Adult-sized cuffs are availab-

– After cleaning, rinse the cuff thoroughly with water

le as standard, small, large and extra

and let it dry at room temperature for about 15 hours.

large.

– The cuffs can be disinfected with isopropyl alcohol

BP cuff suitable for the indicated arm circumference.

70%, ethanol 70%, Microzid, Buraton liquid, Sporicidin or Cidex. After disinfection, rinse the cuff thoroughly with tap water and air-dry.

BP cuff width.

When the cuff is applied, this label must face the skin. When the cuff is applied, these two arrows must be located over the brachial or femoral artery. 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 BP cuff.

CE marking, cuff fulfills EU directives.

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TONOPORT V

17

Application

Applying the Cuff Warning Risk to persons - Disconnect TONOPORT V from other equipment (CASE™, PC) before connecting it to the patient.  Always insert two fully charged NiMH batteries or two new alkaline batteries, before starting a measurement.  Check that the memory has been cleared (see “Clear the Memory” on page 15).  Select the appropriate cuff size (see cuff label). When the cuff is too small the BP values will be overratFig. 4-1 Applying the cuff

ed, when it is too big, the measured values will be too low. Caution Incorrect measurements - – Use only the cuffs listed in chapter 10 "Order Information". – Replace cuffs on a regular basis. Damaged Velcro fasteners may cause incorrect readings.

Index

Index

Index

 Place the cuff on that arm of the patient that is used less frequently during normal daily activities. On adults it should be placed about 2 fingers' breadth above the bend of the elbow; on children, a little closer. Bending the arm must not change the cuff level. Verify that

Fig. 4-2 Applying the cuff

– the cuff tubing points up toward the shoulder (Fig. 4-1) – the side with the

label is on the skin

– the arrow is located above the brachial or femoral artery – the dashed white line at the end of the cuff is located between the two dashed

lines

when you close the cuff (if this is not the case, select another cuff size, Fig. 4-2) – the cuff fits snugly around the arm, but does not compress the blood vessels.

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TONOPORT V

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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 accommodate the cuff connection tube.

– not to move while a measurement is being taken to avoid motion artifacts that may lead to erroneous

 Attach the pouch to the patient (shoulder strap, belt). For reasons of hygiene, it is not advised to carry the pouch on the bare skin.

readings and to keep the cuff inflation time as short as possible – to place TONOPORT V on the night stand while in

 Guide the pressure tubing around the patient's neck as a strain relief and connect it to the blood pressure cuff port on the TONOPORT V (1, Fig. 2-1). Advise the patient to avoid kinking the tubing during the measurement.  Check that the display indicates the time of day. If the memory contains data from a previous procedure, the letter "M" will appear on the display when you turn on the device. If you still try to initiate a measurement, the message "LLLL" prompts you to clear the memo-

bed – how to switch the device manually from the day to the night phase (see page 19) – that events considered important should be noted down in a diary and that intermediate measurements INFO START

can be initiated with STOP

– that the measurement can be stopped at any time with INFO START STOP

(the cuff will be deflated)

ry. Push START twice to delete the data. If you do not STOP

– not to open the battery compartment

wish to delete the data, turn off the device instead of

– about the audio signal and its meaning.

INFO

INFO

pushing START STOP .

Warning

 To avoid erroneous measurements, ensure that the patient does not move during the trial measure-

Risk to persons - Instruct your patient – to terminate the measurement with

ment. The patient may stand or sit.

INFO START STOP

,

whenever the cuff is not deflated within about

INFO  Push START to initiate the first measurement.

2 minutes,

STOP

Within a few seconds, the device starts inflating the cuff.

– to remove the cuff if it is not deflated after

When the inflation pressure has been reached, the cuff will gradually be deflated. The changing cuff pressure is indicated on the display and the letter "M" appears with each detected oscillation. At the end of the measurement the measured data appears in the following order

INFO

activation of the START button. This could be due STOP to kinked tubing. The cuff must be reapplied as described earlier before additional measurements can be taken.

– the systolic reading (S in mmHg or kPa) – the diastolic reading (D in mmHg or kPa) – the pulse rate (HR/min-1). If an error code, such as "E 29" (insufficient number of oscillations detected) is displayed after the measurement, INFO

tighten the cuff a little and push START again (see also STOP chapter 6 "Error Codes"). If the trial measurement has been successfully completed, the device is ready for automatic measurements.

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TONOPORT V

19

Application

General Information on Ambulatory BP Measurement

Toggle Manually Between Day and Night 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. On the display the two phases are represented by the

START STOP

INFO

symbols

starts and stops a measurement displays the most recent measurement results

(day) and

(night).

Patients whose day and night phases are different from INFO

or the most recent error message, toggles

these predefined periods can push the START STOP button twice

between day and night phase (see next section)

to change from one phase to the other.

For the first measurement, the cuff is inflated to a

Note

pressure of 160 mmHg (initial pressure). For subsequent

If the measurement protocol was created with

measurements, the device inflates the cuff to a pressure

CASE™ / CardioSoft and only 1 BP period has

which is 15 mmHg above the systolic value of the

been specified, switching from one phase to the

previous measurement (minimum inflation pressure:

other will leave the measurement intervals

120 mmHg).

unchanged. They will always be the same. The

If the measuring value is above the inflation pressure, the

information "day phase" and "night phase" is only

device will increase the cuff pressure another 50 mmHg. A manual measurement can be taken at any time between the automatic measurements. Manual measurements are

used to identify the measurements.

Audio Signal

identified with the "+" symbol in the tabular BP data.

If enabled (see page 16), the audio signal will be emitted

The device will repeat a measurement after 2 minutes, if

in the following situations:

unsuccessful. An error code referring to failed

– shortly after TONOPORT V was switched on

measurements is generated only after three consecutive

– just before TONOPORT V starts inflating the cuff

unsuccessful measurements.

(during the day phase only)

Error codes E02 (battery depleted), E06 (inflation time over) and E08 (200 measurements taken) do not lead to a

– after TONOPORT V has detected an erroneous measurement

second measurement. The next measurement after error code E06 takes place 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.

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TONOPORT V

2001589-085 Revision F