TONOPORT VI 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. © 2016 General Electric Company. All rights reserved.

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Contents

1

Application, Safety Information

6

2

Controls and Indicators

10

3

Setup

12

4

Application

18

5

Data Output

23

6

Error Codes

24

7

Software Installation

25

8

Cleaning, Maintenance, Disposal

27

9

Technical Specifications

29

10

Order Information

30

11

Appendix - Electromagnetic Compatibility (EMC)

31

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

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2017-01

Initial Release

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General Information

General Information  The product TONOPORT VI bears the CE marking

 This manual reflects the equipment specifications and

CE-0482 (notified body MEDCERT GmbH) indicating its compliance with the provisions of the Council

applicable safety standards valid at the time of printing. All rights are reserved for devices, circuits, tech-

Directive 93/42/EEC about medical devices (including amendment 2007/47/EC) and fulfills the essential

niques, software programs, and names appearing in this manual.

requirements of Annex I of this directive. It has an internal power source and is an MDD class IIa device.

 On request GE Healthcare will provide a Field Service Manual.

The device fulfills the requirements of the Directive

 The safety information given in this manual is classified as follows:

2011/65/EU of the European Parliament and of the Council.  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 606011-2 "Medical electrical equipment – Collateral standard: Electromagnetic compatibility – Requirements and tests" and applicable amendments.

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

 The product is clinical validated. The validation fulfills the standard ISO 81060-2:2013” Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type” and the protocol ESH-IP 2010 from the European Society of Hypertension.  The radio-interference emitted by this product is



Caution indicates a potential hazard. If not avoided, the hazard may result in minor injury and/or product/property damage.  To ensure patient safety and interference-free operation and to guarantee the specified measuring accura-

within the limits specified in CISPR11/EN 55011, class B.

cy, we recommend using only original accessories

The device is certified by UL and thus also fulfills the UL safety requirements.

facturers.

available through GE Healthcare. The user is responsible for application of accessories from other manu-

 The CE marking covers only the accessories listed in the "Order Information" chapter.  This manual is an integral part of the equipment. It should be available to the equipment operator at all times. Close observance of the information given in the manual is a prerequisite for proper equipment performance and correct operation and ensures patient and operator safety. Please note that information pertinent to several chapters is given only once. Therefore, carefully read the manual once in its entirety.  The symbol means: Follow the instructions given in the operator manual. It indicates points which are important to avoid faulty measurements or injuries like strangulation of the arm. 4

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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) Fax:

1 800 668 0732 (Canada only) +1 414 355 3790

The country of manufacture is indicated on the device label.

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Application, Safety Information

1

Application, Safety Information

1.1 Application Biocompatibility

Intended use TONOPORT VI is a small-size, portable blood pressure

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

monitor for ambulatory, non-invasive measurement of the patient’s blood pressure. If the blood pressure cuffs

with the patient during the intended use, fulfill the biocompatibility requirements of the applicable

listed in chapter "Order Information" on page 30 fit the patient, it can be used on adults and pregnant (including

standards if used as intended. If you have questions

pre-eclamptic) women. 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 physician. TONOPORT VI can record up to 400 blood pressure measurements at selectable intervals and save the results. Note CASE™ or CardioSoft version 6.73 SP2 supports only up to 200 memory readings, CardioSoft version 7.0 or later up to 400 memory readings. There is a choice of three different measurement protocols. Using TONOPORT VI with CASE™/CardioSoft TONOPORT VI can be operated in conjunction with CASE™ (version 6.73 SP2 or later) or with the analysis program CardioSoft (version 6.73 SP2 or later) that is included with TONOPORT VI. If the

in this matter, please contact GE Healthcare or its representative.

Oscillometric Measurement Method 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. In order to measure the blood pressure, a blood pressure cuff wrapped around the upper arm needs to be inflated 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.

USB port is used, it is necessary to install the appropriate driver first (see "Software Installation" on page 24). With these systems, individual measurement protocols can be created and the stored data can be reviewed on screen in tabular and graphic form. The patient ID used by the analysis program can be stored in TONOPORT VI 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 DVD). 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

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Application, Safety Information

The inflation measurement method is a novel method based on the "Inflation Measurement Technology (IMT)"

1.2 Functional Description The TONOPORT VI monitor accommodates the blood

developed by PAR Medizintechnik. With this innovative technique, the cuff is inflated to a pressure just above the

pressure measuring system and a microprocessor for sys-

expected systolic value. Once the systolic value is determined, the cuff can immediately and quickly be deflated.

A second microprocessor with a second pressure trans-

tem control and data processing.

The measurement typically takes only approx.

ducer and a second valve are provided for control of the

20 seconds.

technical safety.

If disturbances occur during measurements with the in-

The monitor is powered by two AA size batteries (either

flation measurement method, which may be due to motion artifacts, for example, TONOPORT VI will auto-

rechargeable NiMH batteries or alkaline batteries).

matically switch to the deflation measurement meth- od and complete the blood pressure measurement.

Fig. 1-2 Waveform representing the pressure in the cuff during a measurement using the inflation measurement method: systolic pressure at 125 mmHg, diastolic pressure at 83 mmHg With both methods, a pressure transducer measures the cuff pressure as well as the superimposed pressure pulsations. During blood pressure measurements the cuff must be at heart level. If this is not ensured, the hydrostatic pressure of the liquid column in the blood vessels will lead to incorrect results. When the patient is sitting or standing during measurements, the cuff is automatically at the correct level.

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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 or to parts of systems only when it has been made

where an explosion hazard may occur. Explosion

certain that there is no danger to the patient, the operators, or the environment as a result. To en-

hazards may result from the use of flammable anesthetic mixtures with air or with oxygen, nitrous

sure such a secure connection the equipment or parts of systems have to comply with the standard

oxide (N2O), skin cleansing agents, or disinfectants.

IEC 60601-1 or IEC 62368-1. – 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: o

changes in network configuration

o

connection of additional items (e.g. connecting another TONOPORT device to another port of the PC can lead to

o o

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. – 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 VI 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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Warning

Caution

Incorrect measurements-

Equipment damage, risk to persons-

– Magnetic and electrical fields are capable of interfering with the proper performance of the equip-

– Before connecting the battery charger to the power line, check that the voltage ratings on the

ment. For this reason make sure that external equipment operated in the vicinity of

nameplate match those of your local power line. – The battery charger is not a medical device. Its

TONOPORT VI complies with the relevant EMC requirements. X-ray equipment, MRI devices, radio systems etc. are possible sources of interference as they may emit higher levels of electromagnetic radiation.

use in the patient environment is not permitted. –

Before using the equipment, the operator must ascertain that it is in correct working 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 the housing. For service or repair, please contact your local, authorized dealer (http://gehealthcare.com).

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Controls and Indicators

2

Controls and Indicators 1

Functions of Button 2

Button

INFO

INFO

Function

Message 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

INFO

Button : 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)

6 7

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

8

phase (section "Toggling Between Day and Night Phase" on page 22) and

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

- to program the BP monitor (chapter 3 "Setup" on page 12)

9

2

Connection for blood pressure cuff

10

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

10

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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Controls and Indicators

Explanation of Signs and Symbols

Manufacturer’s identification

Symbols used on the equipment and on the packaging Date of manufacture. The number found under this symbol is the date of manufacture in the YYYY-MM format.

Follow the instructions given in the operator manual. This symbol indicates that the waste of electrical and electronic equipment must not be disposed an unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning if your equipment. Type BF applied part (defibrillationproof, recovery time tR < 1s) Catalogue number

Serial number

Calibration mark, valid in Germany only (see “Technical Inspection of the Measuring System” on page 29) Symbols used on the display Blinks with each detected oscillation; is continuously displayed when the monitor contains data. Blinks when the batteries are almost depleted; is continuously displayed when batteries are discharged and no more BP measurement can be taken. Day phase selected Night phase selected

CE marking CE marked per the Council Directive 93/42/EEC of the European Union. Notified body: MEDCERT GmbH

Further relevant symbols used on the battery charger Polarity of the DC input (charger only)

Gossudarstwenny Standard Russia (GOST)

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

UL-certified product

Protection class II equipment

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

For indoor use only

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

Approval mark for Japan

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

Pollution control symbol according to the Chinese standard SJ/T11363-2006 Restriction of certain hazardous substances. The device fulfills the requirements of the Directive 2011/65/EU of the European Parliament and of the Council.

Keep dry USB port, connection to PC

Serial port, connection to PC

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11

Setup

3

Setup

Inserting Batteries

Some Basic Facts on Battery Power

 Open the battery compartment on the back of

TONOPORT VI is either powered by two rechargeable

TONOPORT VI as shown in Fig. 3-1.

nickel-metal hydride batteries (NiMH) or by two alkaline batteries. The device must be set to the power source used (see section "Inserting Batteries" on page 12). 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 up to 400 blood pressure 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 nickelmetal hydride batteries (from manufacturers such as Sanyo, Panasonic, Energizer, Duracell, Varta, GP) with a capacity > 1500 mAh or high-rate discharge, size AA alkaline batteries (such as Panasonic Evoia, Energizer Ultimate, Duracell Ultra, Duracell Power Pix, 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 charger to recharge the

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

Selecting the Energy Source  Turn on the BP monitor as follows: either by inserting the batteries or by briefly pressing the START button. STOP  Wait for the time to be displayed.  Push

INFO

six times: The display shows "H 6".

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

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

monitor is set up for rechargeable NiMH batteries (as

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

Fig. 3-1 Opening the battery compartment

shipped) and "bbbb" when it is set up for alkaline batteries.  Confirm the displayed information with change the selection with selection with

START STOP

INFO

START STOP

or

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.

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Setup

Charging NiMH Batteries Note The energy source needs to be selected only when the BP monitor is put into service for the first time

Caution Equipment damage, patient hazard - –

or when you change from NiMH to alkaline batteries and vice versa.

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.

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

After quick charging, please wait for some minutes before another quick charge. Otherwise the temperature sensors will not function correctly.

If TONOPORT VI is powered by rechargeable batteries (4 of them are shipped with the equipment), they should be recharged immediately after use (24 hours). Use only the original charger supplied. It consists of an AC power adapter and the charging unit itself.

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Setup

Charging Batteries with the VARTA Charging Unit

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

Fig. 3-3 Battery symbols and bars in 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 the two rechargeable batteries into the charging unit, observing the correct polarity.

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 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. Fig. 3-4 Test display on LCD The minimum battery capacity for a 24-hour measurement is 90%. If the capacity is below 90%, new or fully charged batteries must be inserted. BP monitors that have passed the self-test and completed the battery test will indicate the following information: – the 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, day)

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measuring phase:

15

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 STOP

: the display indicates "0000" if the select-

ed method is the deflation measurement method, or "1111" if the selected method is the inflation meaNote When using TONOPORT VI in conjunction with CASE™/CardioSoft, it is recommended to perform

surement method.  Either confirm with tion with

the first three steps at the PC.

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" on page 23 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

 Push

START STOP

: the display indicates "H 1". : the display indicates "LLLL".

 To delete the data, push

START STOP

again: the display in-

dicates "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 proto-

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

cols:

corrected to change between Standard Time and Daylight Saving Time.

Protocol

Day Phase (7 a.m. to 10 p.m.)

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

 Push

Night Phase (10 p.m. to 7 a.m.)

twice: the display indicates "H 2".

P1

every 15 minutes

every 30 minutes

P2

every 20 minutes

every 40 minutes

P3

every 30 minutes

every 60 minutes

 Push START : The year will be displayed, e.g. "2016". STOP

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

INFO

, then confirm with

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

.

START STOP

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

Selecting a Measurement Protocol

 If the indicated month is correct, confirm it with

 Briefly switch TONOPORT VI off and on again and

or correct it with STOP

START

START

STOP

INFO

wait for the time to be displayed. , then confirm with

.

 Push

INFO

3 times: the display indicates "H 3".

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

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

a protocol automatically clears the memory. If you

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

want to retain the data, switch the BP monitor off.)  Push START : the display indicates "P1" (protocol 1). STOP

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

INFO

INFO

 Either select program 2 or 3 by pushing  confirm the selected protocol with

START STOP

or

.

8 times: the display indicates "H 8".

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

Enabling or Disabling the Audio Signal

 Either confirm with

 Briefly switch TONOPORT VI off and on again and

STOP

tion with

INFO

START STOP

or switch to the other op-

, then confirm with

START STOP

.

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 opSTOP tion with

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INFO

, then confirm with

START STOP

.

17

Application

4

Application

Symbols used on the cuff

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

Follow the instructions given in the operator manual.

Blood pressure cuff fits adult patient of the size marked by the frame (medium, small, large, or ex-

only slightly soiled. – Clean cuffs that are heavily contaminated by washing them with soapy water or a suitable cleaning agent that contains a disinfectant (do not machine-wash). Ensure that no liquid penetrates into the cuff bladder or the pressure tubing.

tra large adults).

– After cleaning, rinse the cuff thoroughly with water and let it dry at room temperature for about 15 hours.

Blood pressure cuff is suitable for

– The cuffs can be disinfected with isopropyl alcohol

the indicated arm circumference. When the blood pressure cuff is

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

applied, this label must face the skin. When the blood pressure 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 blood pressure cuff. CE marking, cuff fulfills EU directives.

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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 two fully charged NiMH batteries or two new alkaline batteries, before starting a measurement.  Check that the memory has been cleared (see "Clearing the Memory" on page 16).  Select the appropriate cuff size (see cuff label). When Fig. 4-1 Applying the cuff

the cuff is too small the BP values will be overrated, when it is too big, the measured values will be too low. Caution Incorrect measurements- – Use only the cuffs listed in chapter "Order Information" on page 30. – Replace cuffs on a regular basis. Damaged Velcro fasteners may cause incorrect readings.  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 elbow. 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) – no compression or restriction of connection tubing can occur – 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. – the cuff and the TONOPORT VI is used inside the ambient conditions for operation and inside the measuring range (s. chapter “Technical Specifications”).

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Application

Warning Risk to Persons- – The effect of blood flow interference can result in a harmful injury to the patient caused by continuous cuff pressure due to connection tubing kinking. – Too frequent measurements can cause injury to the patient due to blood flow interference. – The application of the cuff over a wound can cause further injury. – The application of the cuff and its pressurization on the arm on the side of a mastectomy is not recommended. – The pressurization of the cuff can temporarily cause loss of function of simultaneously used monitoring equipment on the same limb. – 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.

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