TONOPORT V Operators Manual Firmware Ver 2.1 Rev C Oct 2011

Operators Manual

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GE Healthcare

TONOPORT V Ambulatory Blood Pressure System Firmware Version 2.1

Operator’s Manual 2001589-113 ENG US

Revision C

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.

TONOPORT V

2001589-113 Revision C

Contents

Application, Safety Information

Controls and Indicators

Setup

Application

Data Output

Error Codes

Software Installation

Cleaning, Maintenance, Disposal

Technical Specifications

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

Date

Comment

2001589-113 Revision A

2009-05

Initial release

2001589-113 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

2001589-113 Revision C

2011-10-31

“CardioSys “was removed globally Chapters 1.1, 5 and 7: interface restrictions for CASE/ CS were added Chapter 2: relevant battery charger symbols were added Chapter 7: CS 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'

2001589-113 Revision C

TONOPORT V

General Information

General Information y The product TONOPORT V bears the CE marking

y This manual reflects the equipment specifications and

CE-0482 (notified body MEDCERT GmbH)

applicable safety standards valid at the time of printing.

indicating its compliance with the provisions of the

All rights are reserved for devices, circuits, techniques,

Council Directive 93/42/EEC about medical devices

software programs, and names appearing in this

and fulfills the essential requirements of Annex I of this

manual.

directive. It has an internal power source and is an MDD class IIa device.

y On request GE Healthcare will provide a detailed Service Manual.

y It has a type BF applied part.

y The safety information given in this manual is classified

y The product fulfills the requirements of the standard

as follows:

EN/IEC 60601-1 "Medical Electrical Equipment, Part Danger

1: General Requirements for Safety" as well as the electromagnetic immunity requirements of the standard

indicates an imminent hazard. If not avoided, the

EN/IEC 60601-1-2 "Electromagnetic Compatibility –

hazard will result in death or serious injury.

Medical Electrical Equipment" and applicable amendments.

Warning

y The radio-interference emitted by this product is within the limits specified in CISPR11/EN 55011, class B. y

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

The device is classified by CSA INTERNATIONAL and thus also fulfills the UL safety requirements.

y The CE marking covers only the accessories listed in the "Order Information" chapter. y This manual is an integral part of the equipment. It should be available to the equipment operator at all times. Close observance of the information given in the manual is a prerequisite for proper equipment performance and correct operation and ensures patient and operator safety. Please note that information pertinent to several chapters is given only once.

Caution indicates a potential hazard. If not avoided, the hazard may result in minor injury and/or product/ property damage. y 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.

Therefore, carefully read the manual once in its entirety. y The symbol

means: Consult accompanying

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

TONOPORT V

2001589-113 Revision C

General Information

PAR Medizintechnik GmbH 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 1 800 558 7044 (USA only) 1 800 668 0732 (Canada only) Fax +1 414 355 3790

The country of manufacture appears on the device label.

2001589-113 Revision C

TONOPORT V

Application, Safety Information

1.1 Application Biocompatibility

Intended Use

The parts of the equipment described in this manual,

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

including all accessories, that come in contact with

pressure monitor for ambulatory, non-invasive

the patient during the intended use, fulfill the

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

biocompatibility requirements of the applicable

pressure cuffs listed in chapter 10 "Order Information" fit

standards if used as intended. If you have questions in

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

this matter, please contact GE Healthcare or its

children. TONOPORT V is not suitable for blood pressure

representatives.

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™ / CS

The blood pressure cuff is wrapped around the upper arm

TONOPORT V can be operated in conjunction with CASE™ (version 5.15 or later) or with the analysis program CS (version 4.14 or later) that is included

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

with TONOPORT V. If the USB port is used

be level with the heart. If this is not ensured, the hydrostatic

(CS 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 stored

pressure of the liquid column in the blood vessels will lead to incorrect results. y When the patient is sitting or standing during

data can be reviewed on-screen in tabular and graphic

measurements, the cuff is automatically at the correct

form. With V6.5 and subsequent versions, the patient

level.

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 CS manual on the CS 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

TONOPORT V

2001589-113 Revision C

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).

2001589-113 Revision C

TONOPORT V

Application, Safety Information

1.3 Safety Information Danger

Warning

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

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

an explosion hazard may occur. Explosion hazards

or to parts of systems only when it has been made

may result from the use of flammable anesthetic

certain that there is no danger to the patient, the

mixtures with air or with oxygen, nitrous oxide, skin

operator, or the environment as a result. In those

cleansing agents or disinfectants.

instances where there is any 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 60601-1-1 must always be ensured. – TONOPORT V may be connected to CASE™ or to a PC with the CS 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.

TONOPORT V

2001589-113 Revision C

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).

2001589-113 Revision C

TONOPORT V

Controls and Indicators

Connection for blood pressure cuff

Button

INFO

: push to display the most recent

parameter readings. Readings appear in the following order:

- systolic value "S" (unit mmHg or kPa shown on the B N P

display)

T R TA P S TO S

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

F O

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

TO O

P O S D

T R

-1

in /m R H

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

chapter 4, section "Toggle Manually Between Day !

off

and Night Phase") and

0 on

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

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

Fig. 2-1 TONOPORT V controls and indicators

Functions of the Button

INFO

Button

Message

Function

Liquid crystal display (LCD)

Port for connection to PC (USB)

Port for connection to PC (RS232)

Calibration mark

Lid covering battery compartment

(Rechargeable) batteries

ON/OFF switch

Nameplate

on display Push once

clear memory

Push twice

set date and time

Push 3 times

select the measurement protocol

Push 4 times

activate calibration mode

Push 5 times

display firmware version

Push 6 times

select energy source

Push 7 times

enable/disable audio signal

Push 8 times

toggle pressure unit between mmHg and kPa

TONOPORT V

2001589-113 Revision C

Controls and Indicators

Explanation of Signs and Symbols Symbols used on the equipment and on the packaging For indoor use only Caution, consult accompanying documents For indoor use only

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.

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

Type BF applied part (defibrillation-proof)

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

Catalogue number Serial number

Symbols used on the display CE marking M

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

CE marked per the Medical Device Directive 93/42/EEC of the European Union. The notified body is MEDCERT GmbH.

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

Gossudarstwenny Standart Russia (GOST)

day phase selected night phase selected

CSA International classification mark

Further relevant symbols used on the battery charger USB port, connection to PC TR15RA120 100-240V 0.4A 47-63Hz 12V 1.1A

Serial port, connection to PC

Polarity of the DC input (charger only) C

E4 xxx-xx xxxx

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

2001589-113 Revision C

Power supply type designation and ratings

UL-certified product

LISTED

PS E

Approval mark for Japan Pollution control symbol according to the Chinese standard SJ/T113632006

TONOPORT V

Setup

Some Basic Facts on Battery Power TONOPORT V is either powered by two rechargeable Nickel Metal Hydrid batteries (NiMH) or by two alkaline 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.

Fig. 3-1 Opening the battery compartment

Caution Equipment damage - – Only use the original rechargeable, size AA Nickel

Insert Batteries

Metal Hydrid batteries (from manufacturers such as

Note

Sanyo, Panasonic, Energizer, Duracell, Varta, or

Switch TONOPORT V off before inserting the

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

batteries. To do so, slide the ON/OFF switch (10, Fig.

rate discharge alkaline batteries (such as Panasonic

2-1) to the left while looking at the display.

Evoia, Energizer Ultimate, Duracell Ultra, Duracell Power Pix, or Varta maxtech). – Charge the NiMH batteries to capacity before 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

y Hold TONOPORT V as shown in Fig. 3-1 and slide the lid of the battery compartment open (approx. 1 cm). It is not possible to open the lid more than about 1 cm which is just enough to reach the ON/OFF switch. To replace batteries, you must take off the lid (pull upward). y Place the two batteries in the compartment as indicated

NiMH batteries. – Do not attempt to recharge the alkaline batteries.

by the symbols.

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

INFO START STOP

six times: the display shows "H 6".

y Push

INFO START STOP

: the display will show "AAAA" when the

BP monitor is set up for rechargeable NiMH batteries (as shipped) and "bbbb" when it is set up for alkaline batteries.

TONOPORT V

2001589-113 Revision C

Setup

original charger supplied. It consists of an AC power

INFO

y Confirm the displayed information with START STOP or change the selection with selection with

INFO START STOP

adapter and the charging unit itself.

and confirm the new

y Check that the voltage ratings on the nameplate of the charging unit match those of your local power line.

y 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.

y Place the lid on the battery compartment and close.

Note

COMPIT

TC 4

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.

Charge NiMH Batteries Fig. 3-2 Exchanging the connector, connecting the

Caution

charger

Equipment damage, risk to patients - – The charger is not a medical device. It must not be used in the patient environment.

y If necessary, replace the connector to match the wall outlet type: – push the button below the connector and hold it

– The contact surface of the NiMH batteries and

depressed (1, Fig. 3-2)

of the charger must always be kept clean.

– remove the connector and insert the suitable type of

– The charger is to be used indoors only and must

connector 2, 3

be protected against oil, grease, aggressive

– ensure that the new connector locks into place.

detergents and solvents to prevent damage.

y Connect the cable of the AC power adapter to the charg-

– If the charger is damaged in any way, e.g. after a

ing unit 4 and plug the AC power adapter into the wall outlet.

drop or when the mains pins are bent, the local authorized dealer must be contacted immediately. – High temperatures affect the charging process.

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

Ideally, the room temperature should not exceed 40 °C (104 °F). – After quick charging, please wait for some minutes before another quick charge.

Two different charger models are available:

Otherwise the temperature sensors will not

y COMPIT TC4

function correctly.

y VARTA

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 2001589-113 Revision C

TONOPORT V

Setup

Charge Batteries with the VARTA Charger

Charge Batteries with the COMPIT TC4 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 red

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

LEDs corresponds to one of the charger compartments (Fig.

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

3-3). During the charge cycle, the corresponding red LED

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

blinks at a slow rate (approximately once per second). Note:

batteries are inserted, battery symbols will appear in the

If the red LED does not light up, the battery may be inserted

charger display where each symbol corresponds to one of

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

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

is solid red. The charging unit now trickle-charges the battery

cycle, the corresponding bar in the battery symbols blinks.

to compensate for self-discharging.

Note: If the battery symbols and bar do not light up, only

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.

light up, the charger has identified a battery problem. The charging current to the compartment concerned will be cut applicable waste-disposal regulations.

wrong way round. When the batteries are charged, the bars are permanently illuminated. The charging unit now trickle-charges the battery to compensate for self-

If the battery is correctly inserted and the red LED does not

off. Remove the battery and discard, observing the

one battery may be inserted or the batteries are inserted the

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

TONOPORT V

2001589-113 Revision C

Setup

Performance Check

Before using TONOPORT V on a patient

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

clear the memory

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

check date and time and correct, if required

select a measurement protocol

enable or disable the audio signal.

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.

Note

The minimum battery capacity for a 24-hour measurement

When using TONOPORT V in conjunction with

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:

CASE™ / CS, it is recommended to perform the first three steps at the PC.

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

– the time of day – the measuring phase (day

/ night

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

)

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

– whether or not data are stored in the BP monitor (M) (Fig. 3-6).

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

The BP monitor will also emit an audio signal, if enabled.

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

kPa

mmHg

Fig. 3-5 Test display on LCD

y Push

INFO START STOP

: the display indicates "H 1".

y Push

INFO START STOP

: the display indicates "LLLL".

y To delete the data, push

INFO START STOP

again: the display indi-

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

M Fig. 3-6 Example: display after successful self-test (M= BP data in memory, measuring phase: day)

2001589-113 Revision C

TONOPORT V

Setup

Time and Date

Measurement Protocols

Usually the BP monitors are set to the correct time and date

There is a choice of three different measurement protocols:

before delivery. Therefore, the time only needs to be 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 Date and Time

every 15 minutes

every 30 minutes

y Briefly switch TONOPORT V off and on again and

every 20 minutes

every 40 minutes

every 30 minutes

every 60 minutes

wait for the time to be displayed. y Push

INFO START STOP

twice: the display indicates "H 2".

y Push

INFO START STOP

: the display indicates the year, e.g. "2009".

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

INFO

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

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

Select a Measurement Protocol y 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

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

INFO START STOP

INFO

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

INFO

and confirm with START . STOP

protocol automatically clears the memory. If you do not

y In the same manner, correct day, hour and minute. y In the end, the time of day will be displayed again. Selecting the Pressure Unit y Briefly switch TONOPORT V off and on again and wait for the time to be displayed. y Push

INFO START STOP

wish to clear the memory, turn the BP monitor off.) INFO y Push START : the display indicates "P1" (protocol 1). STOP

INFO

y Using START , select protocol 2 or 3 STOP OR

eight times: the display indicates "H 8".

INFO

y Confirm the displayed protocol with START STOP .

INFO

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

y Confirm the pressure unit with START or select the other STOP unit with

INFO START STOP

, then confirm with

INFO START STOP

Enable or Disable the Audio Signal y Briefly switch TONOPORT V off and on again and wait for the time to be displayed. INFO

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

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

INFO

y Either confirm the setting with START or press START to seSTOP STOP INFO

lect the alternate setting and confirm with START . STOP

TONOPORT V

2001589-113 Revision C

Application

Symbols used on the cuff

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

Refer to Operator Manual.

slightly soiled. – Clean cuffs that are heavily contaminated by washing

Cuff suitable for adult patients of the

them with soapy water or a suitable cleaning agent that

indicated height (see man in box).

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

Adult-sized cuffs are available as

that no liquid penetrates into the cuff bladder or the

standard, small, large and extra large.

pressure tubing (for this reason, remove the bladder from the cuff before cleaning).

BP cuff suitable for the indicated arm circumference.

– After cleaning, rinse the cuff thoroughly with water and let it dry at room temperature for about 15 hours. – The cuffs can be disinfected with isopropyl alcohol 70%, ethanol 70%, Microzid, Buraton liquid,

BP cuff width.

Sporicidin or Cidex. After disinfection, rinse the cuff thoroughly with tap water and air-dry.

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.

2001589-113 Revision C

TONOPORT V

Application

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

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

y 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 – the cuff tubing points up toward the shoulder (Fig.

Fig. 4-2 Applying the cuff

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.

TONOPORT V

2001589-113 Revision C

Application

Initiate a Trial Measurement

Patient Information

y 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.

avoid motion artifacts that may lead to erroneous

y 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. 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. y 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 memory. Push

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

y Guide the pressure tubing around the patient's neck as a

INFO START STOP

– not to move while a measurement is being taken to

twice to delete the data. If you do not wish to

– 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 can be INFO START

initiated with STOP

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

(the cuff will be deflated)

– not to open the battery compartment – about the audio signal and its meaning.

delete the data, turn off the device instead of pushing INFO START STOP

y To avoid erroneous measurements, ensure that the patient does not move during the trial measurement.

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

INFO START STOP

whenever the cuff is not deflated within about

The patient may stand or sit.

2 minutes,

INFO y Push START to initiate the first measurement.

– to remove the cuff if it is not deflated after

STOP

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

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 measured data appears in the following order – 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

chapter 6 "Error Codes").

STOP

If the trial measurement has been successfully completed, the device is ready for automatic measurements.

2001589-113 Revision C

TONOPORT V

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 7

ambulatory blood pressure measurement:

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 symbols

START STOP

INFO

starts and stops a measurement

(day) and

displays the most recent measurement results or

Patients whose day and night phases are different from

the most recent error message, toggles between day and night phase (see next section)

(night).

INFO

these predefined periods can push the START STOP button twice to change from one phase to the other.

For the first measurement, the cuff is inflated to a pressure of 160 mmHg (initial pressure). For subsequent measurements, the device inflates the cuff to a pressure which is 15 mmHg above the systolic value of the previous measurement (minimum inflation pressure: 120 mmHg).

Note If the measurement protocol was created with CASE™ / CS and only 1 BP period has been specified, switching from one phase to the other will leave the measurement intervals unchanged. They

If the measuring value is above the inflation pressure, the

will always be the same. The information "day

device will increase the cuff pressure another 50 mmHg.

phase" and "night phase" is only used to identify the

A manual measurement can be taken at any time between

measurements.

the automatic measurements. Manual measurements are identified with the "+" symbol in the tabular BP data.

Audio Signal

The device will repeat a measurement after 2 minutes, if

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

unsuccessful. An error code referring to failed

the following situations:

measurements is generated only after three consecutive unsuccessful measurements.

– shortly after TONOPORT V was switched on – just before TONOPORT V starts inflating the cuff

Error codes E02 (battery depleted), E06 (inflation time over) and E08 (200 measurements taken) do not lead to a second measurement. The next measurement after error code E06 takes place at the selected interval.

(during the day phase only) – after TONOPORT V has detected an erroneous measurement

After error codes E02 and E08, the device enters the powersave mode to prevent over-discharging of the rechargeable batteries. This mode can only be terminated by turning the device off and on again.

TONOPORT V

2001589-113 Revision C

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Corometrics

TONOPORT System

TONOPORT V Operators Manual Firmware Ver 2.1 Rev C Oct 2011