boso CA01, CA02, Manschette Standard CA01, Manschette XL CA02 User Instructions

medicus
Gebrauchs-
anweisung
User
Instructions
Mode
d’emploi
Manuale
Manual
del Usuario
2
33
64
95
126
33
Table of contents
Product features.....................................................................................................................................................................................................................35
Contents of package
......................................................................................................................................................................................................36
Quick guide
...................................................................................................................................................................................................................................37
Introduction...................................................................................................................................................................................................................................38
Blood pressure values
....................................................................................................................................................................................................40
Systolic and diastolic blood pressure value
...............................................................................................................40
WHO blood pressure cut-off values
.......................................................................................................................................40
Starting up
......................................................................................................................................................................................................................................42
Inserting batteries
........................................................................................................................................................................................42
Battery status
.......................................................................................................................................................................................................43
Care for the environment
.........................................................................................................................................................................................43
General instructions for self-measurement
....................................................................................................................................44
Preparing to measure your blood pressure
....................................................................................................................................46
Note on cuff sizes
..........................................................................................................................................................................................46
Attaching the cuff
..........................................................................................................................................................................................48
Measuring your blood pressure.......................................................................................................................................................................51
Interrupting a measurement
.............................................................................................................................................................52
Measurement display
.....................................................................................................................................................................................................53
Mains operation
...................................................................................................................................................................................................................55
Error messages
.........................................................................................................................................................................................................................56
Cleaning and Disinfection
........................................................................................................................................................................................57
Warranty
........................................................................................................................................................................................................................................57
Customer service / Disposal
..................................................................................................................................................................................58
Technical data
............................................................................................................................................................................................................................59
Calibration checks - Testing instructions (for trained specialist staff only)
....................................................................................................................................................................62
34
Table of contents
35
Mains connector
pressure selector switch
START/STOP button
LCD display
Cuff connector
Product features
Battery status display see page 43 Measurement in progress see page 52
36
Contents of package
1 boso medicus
blood pressure monitor
1 CA 04 universal
cuff
1 Case
1 Blood pressure
record card
BOSCH+SOHN GMBH U. CO. KG FABRIK MEDIZINISCHER APPARATE BAHNHOFSTR. 64 · D-72417 JUNGINGEN
Diese Garantie-Urkunde ist nur gültig in Verbindung mit einem Kaufbeleg.
This warranty certificate is valid only in combination with a proof of purchase (invoice).
Ce certificat de garantie est valable uniquement sur présentation d'une preuve d'achat (facture)
Este certificado de garantía es válido sólo en combinación con una prueba de compra (factura).
Questo certificato di garanzia è valido solo in combinazione con una prova di acquisto (fattura).
GARANTIE-URKUNDE
CERTIFICATE OF WARRANTY
CERTIFICAT DE GARANTIE
CERTIFICADO DE GARANTIA
CERTIFICATO DI GARANZIA
medicus
Gebrauchs­anweisung
User
Instructions
Mode
d’emploi
Manuale
di istruzioni
Manual
del Usuario
2
33
64
95
126
1 Warranty certificate
4 LR 6 (AA) batteries
1 User
instructions
Blutdruckpass
Blood pressure record card
Carnet de tension arterielle
Diario de la pressione arteriosa
Carnet de presion arterial
37
Quick guide
Insert batteries, ensure correct position-
ing (P. 42)
Connect cuff to monitor (P. 46)
Attach cuff (P. 47)
Start (and stop) a measurement by
pressing the START/STOP button (P. 51)
Measured systolic, diastolic and pulse values are displayed after the measure­ment is completed (P. 53)
This quick guide does not replace the
detailed information on the use and safety of the blood pressure monitor fea­tured in the user instructions.
Please be sure therefore to read the user instructions!
38
Introduction
Dear Customer, We are delighted that you have decided to purchase a boso blood pressure mon­itor. The boso brand is synonymous with optimal quality and precision and is also number 1 among professionals: 77% of all German doctors currently use boso blood pressure monitors. The experience gained from decades of use by profession­als has also been incorporated into all the patient monitors for home measure­ment. This instrument has also passed our strict quality control procedures and is your reli­able partner for monitoring your blood pressure values.
Please read these user instructions
before using the instrument for the first time, as correct blood pressure readings
can only be obtained if the instrument is operated correctly. In these user instructions, „“ means an action by the user.
To get help concerning usage or mainten­ance please contact your dealer or the manufacturer (contact details can be found on the back cover of this manual).
An unexpected operating condition or an incidence which has worsened the health condition or could have worsened the health condition should be reported to the manufacturer immediately.
If the instrument is to be sold, ensure that these user instructions are enclosed.
39
Introduction
If the monitor is used in medical practice (in accordance with the legislation govern­ing the operation of medical devices), it should be calibrated at regular intervals (see page 62).
The boso medicus blood pressure monitor is suitable for patients of all ages with an upper arm circumference of be-tween 22 and 48 cm. The monitor is not suitable for neonatals.
Wireless communication devices, such as home networking devices, mobile phones, cordless phones and their base stations, walkie-talkies can affect this blood pres­sure monitor. Therefore, a minimum distance of 11 feet should be kept from such devices.
40
Blood pressure values
To determine the blood pressure, two val­ues need to be measured:
Systolic (upper) blood pressure:
This is produced when the heart muscle contracts and blood is forced into the blood vessels.
Diastolic (lower) blood pressure:
This is present when the heart muscle ex­pands and fills with blood again.
Blood pressure measurement values are expressed in mmHg (mm of mercury).
systolic diastolic
High blood pressure (hypertension) over 140 mmHg over 90 mmHg
Borderline normal blood pressure 130 to 139 mmHg 85 to 89 mmHg
Normal blood pressure 120 to 129 mmHg 80 to 84 mmHg
Optimum blood pressure up to 119 mmHg up to 79 mmHg
The World Health Organization (WHO) has defined the following cut-off values for assessing blood pressure:
41
Blood pressure values
Whether medical treatment is necessary depends not only on the blood pressure, but also on the patient’s risk profile. Please contact your GP if one of the val­ues (systole, diastole) consistently exceeds the cut-off point for high blood pressure.
Self-measurement of blood pressure often produces somewhat lower values at home
than at the doctor’s. The German Hypertension League has therefore defi­ned lower cut-off values for home measu­rements:
Home measurement: 135/85 mmHg Measurement in the doctor’s surgery: 140/90 mmHg
42
Starting up
Use only high quality leak-proof batter-
ies of the correct specifications (see “Technical data” P. 59).
Never mix old and new batteries or
different makes.
If the batteries are not inserted cor-
rectly, the monitor will not work and this may cause the batteries to heat up and leak, damaging the monitor.
Inserting the batteries
The battery compartment is located on the underside of the monitor. Insert bat­teries in the battery compartment as shown in illustration 1.
Remove the batteries if the monitor is
not to be used for any length of time.
+
+
+
+
Illustration 1
The device must be installed and put into operation in accordance with the instruc­tions in this manual.
43
Starting up
The monitor has a battery status display (see P. 35)
Flashing! No further measurements possible. Replace battery.
Care for the environment
Do not dispose of used batteries and charger units in domestic waste. You can take these to collection sites for used batteries or special waste. Contact your local authority for informa­tion.
44
General instructions for self-measurement
1. Fluctuations in blood pressure are quite normal. Even when measurements are repeated, there can be marked differ­ences. Single or irregular measure­ments do not provide reliable informa­tion about the actual blood pressure. A reliable evaluation is only possible if reg­ular measurements are taken under comparable conditions and the measure­ment values entered in the blood pres­sure record card.
2.
Self-testing does not mean self-
treatment. Do not on any account change the dose of medicine prescribed by your doctor of your own accord.
3. Irregular heartbeats can affect the accu­racy of the monitor or result in incorrect measurements.
4. Incorrect measurements can also occur in patients with a weak pulse (possibly in patients wearing a pacemaker, for ex­ample). The blood pressure monitor it­self has no effect on the pacemaker.
5. If you are pregnant, consult your doctor before using the monitor.
6. Always take the measurement in a calm and relaxed state. You are recommended to check your blood pressure twice a day – in the morn­ing on getting up and in the evening once you have relaxed after work.
7. Always measure your blood pressure from the arm with the higher blood pressure values (where not required otherwise (see page 49)).
45
General instructions for self-measurement
To do this, measure the blood pressure
first in both arms and thereafter always from the arm with the higher blood pressure.
46
Note on cuff sizes:
The monitor may only be used with
the following cuff types. These should be chosen according to the upper arm cir­cumference printed on them.
* Cuff supplied as standard.
Type Arm Order number
circumference
CA01 22 – 32 cm 143-4-760*
CA02 32 – 48 cm 143-4-757
Preparing to measure your blood pressure
Attach the cuff to the monitor by pressing the plug (click) into the socket on the left side of the unit. (See illustration 2).
Illustration 2
47
Preparing to measure your blood pressure
Set the pressure selector switch
‘DRUCKVORWAHL’ to the desired cuff pressure which should be at least 30 to 40 mmHg higher than the systolic (upper) blood pressure reading. If you are not sure of this value, set the selec­tor switch to 150 mmHg for the first measurement.
If this pressure is insufficient, the unit will switch over to the next higher pres­sure setting automatically.
Illustration 3
48
Preparing to measure your blood pressure
Observe the following instructions when measuring your blood pressure:
Avoid smoking or drinking coffee for one hour before measuring your blood pressure.
Sit comfortably for the blood pres­sure measurement. Support your back and arms. Do not cross your legs. Place your feet flat on the floor. Relax for 5 minutes before taking a measurement. Do not move during the measure­ment.
Attaching the cuff
The measurement should be taken from the bare upper arm.
In the case of tightly fitting outer
clothing, ensure that the blood supply to the arm is not cut off when the sleeve is rolled up (if necessary remove the article of clothing before taking the measurement).
Open out the cuff into the shape of a
ring and slide it over the upper arm until the bottom edge of the cuff is about 2-3 cm above the elbow. The cuff must be positioned so that the marking is over the artery (see illustra­tion 3).
49
Preparing to measure your blood pressure
Do not attach the cuff over wounds as
this can cause further injuries.
Ensure that the cuff is not attached to
an arm where arteries or veins are under­going or have undergone medical treat­ment (e.g. shunt).
For women who have had a breast
amputated, do not attach the cuff to the arm on the amputated side of the body.
During the measurement, medical ap-
paratus that are being used on the same arm at the same time, may malfunction.
The cuff must not be too tight. There
should be enough space to fit roughly two fingers between arm and cuff.
The metal ring should never lie over
the artery (see illustration 4) as this may produce a false reading.
Grasp the end of the cuff that feeds
though the metal ring and wrap it around the outside of your arm. Attach the Velcro fastener by applying gentle pressure.
2-3 cm
Marking
Artery
Illustration 4
50
Preparing to measure your blood pressure
Place your arm with the cuff attached
on the table, holding it relaxed and slightly bent so that the cuff is level with your heart.
Do not talk during the measure-
ment.
correct values
too low values
too high values
Illustration 6
Check that the air tube is not kinked
during the measurement. This could cause congestion of the blood flow and sub­sequent injury.
The blood pressure measurement
should not prevent the flow of blood for an unnecessary length of time (> 2 minutes). If the monitor fails to function correctly, re­move the cuff from the arm.
Excessive frequent measurements can
cause injury by restricting blood flow.
51
Measuring your blood pressure
Start the measurement with the
START/STOP button
Now hold the arm absolutely still and
do not talk.
All the items on the LCD display appear briefly to indicate that the monitor is now ready for use (see illustration 6).
Illustration 6
Systole mmHg
Diastole mmHg
Pulse/min.
52
Measuring your blood pressure
The unit now inflates the cuff to the prese­lected cuff pressure.The rise in pressure in the cuff is indicated on the digital display.
An acoustic signal sounds once the prese­lected pressure has been reached. The pump switches off and the air in the cuff escapes automatically.
Interrupting a measurement:
A measurement can be interrupted at any stage by pressing the start button; the cuff deflates automatically.
During the measurement phase, the fall­ing pressure and the symbol are indi­cated on the display.
Illustration 7
53
The measured blood pressure values (systole, diastole, pulse) are displayed (see illustration 8).
Measurement display
As soon as the unit registers the first beats, the symbol blinks in time with the pulse rhythm and an acoustic signal can be heard.
The end of the measurement is indicated by a long beeping sound.At the same time, the built-in solenoid valve opens automa­tically to rapidly release the remaining pressure in the cuff.
Systole mmHg
Diastole mmHg
Pulse/min.
Illustration 8
54
Measurement display
Blood pressure is a dynamic parameter and can be affected by the patient’s position, e.g. sitting, standing, lying, moving, before or during the measurement, physical con­dition (stress, disease, etc.).
If the measurement result is obviously
wrong, repeat the measurement.
The unit switches itself to time display mode automatically after about 1 min. To repeat a measurement, press the START/STOP button again briefly.
Allow at least two minutes be­tween measurements.
If no further measurement is required,
remove the cuff from the arm.
Enter each individual value in your
record card.
2
min
55
Mains operation
The mains connection socket is located at the rear of the monitor. Where required, use only the boso power supply unit (order number 410-7-150). This power supply unit produces a rectified output of the correct polarity. Other com­mercially available power supply units can cause damage to the electronic compo­nents, which will invalidate the warranty. There is also a risk of fire with these other power supply units.
56
Error messages
If any problems occur during the measurement, the display will show an error message instead of a blood pressure reading.
Meaning of error messages:
Fehlerbehebung
Inflation pressure inadequate after Select the next higher pressure two attempts to inflate setting
No pulses were detected that Check the positioning of the cuff could be evaluated
Leak in the air system Check air connector on cuff.
Cuff possibly defective.
Fehlerursache für Err-Anzeige
57
Cleaning and Disinfection Warranty
Cleaning Monitor:
Use a soft, dry cloth to clean your monitor.
Cleaning Cuff:
Small stains on the cuff can be removed carefully with a proprietary washing-up liquid.
Disinfection Cuff:
For disinfectant wipes (at least 5 minutes exposure time) of the device and the cuff, we recommend the disinfectant mikrozid sensitive liquid (Schülke & Mayr). To disinfect the velcro of the cuff, we re­commend spray disinfection. In particular, if the device is used on multi­ple users is to pay attention to regular cleaning and disinfections of the cuff.
Warranty:
For details of the warranty conditions, please consult the warranty certificate supplied. A claim under the warranty will only be accepted if the warranty certificate, completed and stamped by the dealer, is returned with the monitor.
58
Disposal
Do not dispose of monitors and bat­teries in the domestic waste.
At the end of its lifespan, the monitor must be taken to a collection site for obsolete electronic items.
Please note that batteries and recharge­able batteries must be disposed of separ­ately (local authority collection site).
Expected operational lifetime of the equip­ment: 10 years.
Expected operational lifetime of the cuff:
10.000 measurement cycles.
Customer service
Customer service:
Warranty and repair work must be under­taken by trained and authorised personnel. Do not modify this equipment without aut­horization of the manufacturer. Send the monitor, carefully packaged and with sufficient postage, to your authorised dealer or directly to:
BOSCH + SOHN GmbH u. Co. KG Serviceabteilung Bahnhofstraße 64, D-72417 Jungingen T: +49(0) 74 77 / 92 75-0
59
Measurement principle: oscillometric
Measurement range: 40 to 280 mmHg, 40 to 200 pulses/min.
Cuff pressure: 0 to 320 mmHg
Display: LCD
Operating conditions: environmental temperature +10°C to +40°C
Relative humidity 15 to 85%
Storage conditions: environmental temperature -10°C to +60°C
Relative humidity 15 to 85%
Power supply: DC 6 V (4 x 1.5 V Mignon IEC LR 6 alkaline manganese
batteries) Alternative special option: DC 6 V power supply unit, Order No. 410-7-150
Typical battery life: 1.000 measurement cycles
(depending on inflation pressure and frequency of use).
Technical data
Battery check: symbol display in LCD window
Weight: 400 g without batteries
Dimensions (WxHxD): 165 mm x 70 mm x 110 mm
Classification: Protection class II ( )
Type BF ( )
Protection against solid IP20 objects:
Clinical test Accuracy complies with the requirements (DIN 58130): of EN 1060 Part 3
Maximum deviation of cuff ± 3 mmHg pressure measurement:
Maximum deviation of ±5% pulse rate display:
60
Technical data
61
Applicable standards: EN 1060, Part 1: “Non-invasive sphygmomanometers –
General requirements” and Part 3: “Supplementary requirements for electro-mechanical blood pressure
measuring systems”.
Technical data
62
Calibration checks – every 2 years at the latest – must be performed by the follow­ing institutions or persons: – Manufacturer – Trade measurements authorities – Persons who fulfil the requirements of
the legislation governing the operation of medical devices.
A) Function testing
Function testing of the monitor can only be carried out on a person or with a suitable simulator.
B) Testing of pressure circuit integrity
and deviation of pressure display
Calibration checks - Testing instructions (for trained specialist staff only)
Note:
a) When the pressure in measurement
mode increases above 320 mmHg, the quick release valve is triggered and the pressure circuit opens.When the press­ure in test mode increases above 320 mmHg, the measured value display flashes.
b) Remove the plug from the cuff tube for
testing. Then attach the short connec­ting piece of the plug – previously inserted into the socket on the monitor – to the cuff tube and insert the long connecting piece of the plug into the monitor. A pump ball must also be introduced into the pressure circuit.
63
Calibration checks - Testing instructions (for trained specialist staff only)
Testing
1.) Switch off the unit.
2.) Set the pressure preselector switch to 150 mmHg.
3.) Press the START/STOP button momen­tarily.
4.) When „0“ is flashing set the pressure selector switch to 240 mmHg and then back again to 150 mmHg.The unit is in test mode when the display indicates SYSTOLE, DIASTOLE and PULSE 0 mmHg.
5.) Perform the usual tests for – tolerance testing of the pressure
reading.
– leak testing of the pressure circuit
(take account of the cuff’s settlingtime of one minute).
6.) Switch off the unit and restore the ori­ginal connections.
C) Security
For security purposes the two halves of the unit can be joined together with a security mark. Alternatively the hole for the casing connector screw on the rear side of the unit can be secured by sealing it.
BOSCH + SOHN GmbH u. Co. KG Bahnhofstraße 64 D-72417 Jungingen
T + 49 (0) 74 77 9275-0 F + 49 (0) 74 77 1021 E zentrale@boso.de
Internet: www.boso.de
07/2013
0124
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