1806 Recorder Manual

VASOMEDICAL-BIOX 1806/1807 AMBULATORY BP RECORDER USER MANUAL
USER MANUAL
CB-1806-B/CB-1807-B
BIOX3.899.0023.V04
Feb. 2017
© Vasomedical, Inc. and BIOX™ Instruments Co., Ltd.
Table of Contents
1 LIMITED WARRANTY AND TECHNICAL SUPPORT ...................................................... 3
1.1 Limited Warranty .................................................................................................... 3
1.2 Technical Support and Service ............................................................................... 3
2 INTRODUCTION ............................................................................................................. 4
2.1 About This Manual ................................................................................................. 4
2.2 Intended Use .......................................................................................................... 4
2.3 Contradictions ........................................................................................................ 4
2.4 Proper Environmental Conditions ........................................................................... 5
2.5 Cautions ................................................................................................................. 5
2.6 Symbols ................................................................................................................. 6
3 PRODUCT INFORMATION ............................................................................................. 8
3.1 Features ................................................................................................................. 8
3.2 Recorder Illustration ............................................................................................... 8
3.3 Items in a Package ................................................................................................. 9
3.4 Specifications ........................................................................................................10
4 PREPARATIONFOR RECORDING ................................................................................ 11
4.1 Batteries ................................................................................................................ 11
4.2 SD Card ................................................................................................................ 11
4.3 Cuff Preparation for Blood Pressure Measurement ...............................................14
5 OPERATION OF RECORDER .......................................................................................16
5.1 General Info about Recorder Interface and Operation ..........................................16
5.2 Main Menu Screen ................................................................................................16
5.3 Recorder Settings..................................................................................................17
5.4 Recording Parameter Settings with ARCS ............................................................21
5.5 Wireless Communication.......................................................................................22
5.6 About Recorder .....................................................................................................22
5.7 Blood Pressure Measurement ...............................................................................23
5.8 Start Recording .....................................................................................................24
5.9 Keypad Unlocking .................................................................................................26
1
5.10 Recording Finished ............................................................................................27

6 MAINTENANCE .............................................................................................................28
6.1 General .................................................................................................................28
6.2 Cleaning of Recorder and Accessories .................................................................28
6.3 Storing ...................................................................................................................28
6.4 Calibration .............................................................................................................28
6.5 Disposal ................................................................................................................28
7 TROUBLESHOOTING....................................................................................................29
7.1 Recording Time Less Than 1 Day .........................................................................29
7.2 Memory Card Issues .............................................................................................30
7.3 BP Measurement Issues .......................................................................................30
7.4 Bluetooth Communication Issues ..........................................................................31
8 REFERENCE TO STANDARDS .....................................................................................33
8.1 International Standards .........................................................................................33
8.2 EMC Information ...................................................................................................33
9 CONTACT INFORMATION .............................................................................................37
2
1 LIMITED WARRANTY AND TECHNICAL

SUPPORT
1.1 Limited Warranty
Vasomedical, Inc. warrants the Vasomedical-BIOX™ 1806/1807 Ambulatory Blood Pressure

Recorder to be free from defects in workmanship and materials under normal use and service
for one (1) year from date of shipment. If a product proves to be defective during the warranty
period, it is the responsibility of Vasomedical, Inc. to repair or replace, at its option, the
defective parts. The foregoing will be the sole warranty remedy. However, no warranty is
provided if the products are modified without the express written consent of Vasomedical, Inc.
and Vasomedical, Inc. shall not be liable in any event for incidental or consequential damage.
This warranty is not transferable.
Factory: BIOX™ INSTRUMENTS CO., LTD.
100 Dicui Road 530 Building 1,19th Floor BinHu District,
Wuxi,Jiangsu 214072,P.R.C
1.2 Technical Support and Service
Repairs of Vasomedical products under warranty must be made only by properly trained
service personnel, authorized by Vasomedical Inc. to perform such procedures. For more
information, please contact:
Manufacturer: VASOMEDICAL, INC.
137 Commercial Street
Suite 200
Plainview, New York 11803
TEL: (800) 455-3327
Or: (516) 997-4600
FAX: (516) 997-2299
The above contact information is for North American clients only. All other clients please
contact your local distributor for service information.
3
2 INTRODUCTION
2.1 About This Manual
This is an operation manual for CB 1806/1807 Ambulatory Blood Pressure Recorder. Not
limited to instructions mentioned in this manual, some special demand might be required by
appropriate hardware and associated software. Please read this manual carefully before
using devices.
Please check the package list which is inside the recorder package, and contact the
manufacturer or distributor if you have any questions.
All the modification and issuing rights belong to BIOX Instruments CO., Ltd. Other individuals
or organizations have no right to copy, modify and issue this manual without permission from
BIOX Instruments CO., Ltd.
Table 2.1 Version History
Document number and version Date Issued
BIOX3.899.0023.V04 2017.2
2.2 Intended Use
Vasomedical-BIOX 1806/1807 Ambulatory Blood Pressure Recorder is a non-invasive device

intended to acquire ambulatory blood pressure signals from the upper body surfaces. The
recorder is intended for adults and children who are over the age of twelve years. The
Vasomedical-BIOX ARCS Series Analysis, Reporting and Communication Software allows
transfer of data from the recorder to a Windows, PC-based computer program via a
removable and large capacity memory card (SD card) for the purpose of creating reports and
printouts. The Software does not perform diagnosis. Physicians carry out diagnostic
evaluations of the data. The system is only for measurement, recording and display, and
makes no diagnosis.
2.3 Contradictions
Patients sensitive to electric static discharge (ESD).
4
2.4 Proper Environmental Conditions
Magnetic and electric fields may interfere the recorder, so make sure the electric devices
around the recorder should meet relevant EMC requirements. Listed below are some
warnings but not limited to:
 Patients should be aware to avoid being close to electromagnetic interference sources,

such as CT, MRI equipment.
 Keep away from high voltage lines, transformers and welding machines.
 Do not get too close to TV and car engines.
 Avoid using cell phones and other telecommunication equipment while wearing the
recorder.
 Using the recorder with defibrillation and other elector-physiological examination is

strictly prohibited.
 To reduce the interference from static electricity, patients are advised to wear natural
material clothes, such as cotton clothes; avoid wearing fiber material clothes, such as
chemical fiber.
 Avoid using electric blankets or heating-water bed for sleep warm-up.

Do not use the recorder in environment full of flammable anesthetic agents, flammable gases,
flammable cleansing agents and other inflammable agents. Do not use the recorder in the
dusty or severe damp environment. Do not swim, take bath or shower during the recording.
2.5 Cautions
Remove electrodes and disconnect the lead-wires from patient before defibrillation. This
recorder is not suitable for using with electrosurgery or HF surgical equipment. The
conductive parts of electrodes and associated connectors are type CF, and should not
contact other circuitry including ground.
The recorder should be used under physician’s guidance. Diagnosis can only be made by
physicians.
Check the lead-wires and electrodes, and replace them immediately if damaged.
The recorder is precise electronic equipment. Use carefully without any striking or beating.
During recording, please do not take the recorder out of the carrying case or remove battery.
When the recorder is not in use, please remove batteries out of the recorder to avoid battery
liquid leakage.
Blood pressure measurement accuracy will be reduced in the presence of arrhythmia.
5
The patient position, such as physical exercises (walking, cycling, etc.) during the
measurement, oscillation caused by loud talking during air deflation, BP cuff loosened, will
affect the blood pressure measurement result, leading to unusable result or measurement
failure.
Patients need to be advised by their physicians to take off cuffs by themselves if inflation
status is longer than three minutes.
Do not measure blood pressure frequently in a short period, what could cause harm to
patients.
During a blood pressure measurement, monitoring devices, such as Pulse Oximeter, might
not work normally.
Measuring blood pressure might interfere some treatments, such as intravenous injection.
The recorder, whose blood pressure measurement is based on oscillatory method, might not
measure blood pressure accurately on some patients with special conditions.
The expected lifetime of this type of recorder is 5 years. After this period, the possibility of
component failure will be higher due to component aging. No modification of this equipment
is allowed.
2.6 Symbols
Table 2.2 Symbol list

THEREGISTEREDBRANDOFBIOXINSTRUMENTS
CO., LTD
THE REGISTERED BRAND OF VASOMEDICAL
INSTRUMENTS
DEFIBRILLATION-PROOFTYPE BF APPLIED
PART FOR BP
IN COMPLIANCE WITH ALL RELEVANT AND EFF
ECTIVE EC DIRECTIVES AND NOTIFIED UNDER
NO. 0197 TO THE EC COMMISSION BY NOTIFIED
BODY TUV RHEINLAND.
SERIAL NUMBER
MANUFACTURER
6
THIS END UP.
FRAGILE, HANDLE WITH CARE
KEEP DRY
TEMPERATURE LIMITATION (VALUES STATED AS

PART OF THE SYMBOL PROVIDES THE MINIMUM
AND MAXIMUM TEMPERATURES)
HUMIDITY LIMITAION (VALUES STATED AS PART
OF THE SYMBOL PROVIDE THE MINIMUM AND
MAXIMUM RELATIVE HUMIDITY)
ATMOSPHERIC PRESSURE
ok CONFIRM BUTTON
< LEFT BUTTON
> RIGHT BUTTON
CONSULT INSTRUCTIONS FOR USE
DISPOSAL OF WASTE ELECTRICAL /

ELECTRONIC ACCORDING TO THE RAEE
DIRECTIVE
Note:
Product number：YYMM-18XX-NNNN
YY: Manufactured year
MM: Manufactured month
XX: 06/07
NNNN: product code
7
3 PRODUCT INFORMATION
3.1 Features
Ambulatory Blood Pressure (BP) Recorder is manufactured by BIOX Instruments Co., Ltd. It
employs advanced signal processor and large capacity memory card (SD card) to record
blood pressure measurements, without data compression for 24 – 48 hours. Recorded data
can be loaded to a computer using software, allowing for analysis and reports generation.
The 18 Series Ambulatory BP recorder models covered in this manual include CB-1806-B,
CB-1807-B. The differences between these two models are given in Table 3.2.
3.2 Recorder Illustration
BP Cuff Socket
LCD
Control
Buttons
(a)
8
Battery
Compartment
(b)
Fig.3.1 1806/1807 Ambulatory Blood Pressure Recorder
3.3 Items in a Package
Table 3.1 Standard Accessories

Card Carrying
Recorder Memory Card BP Cuff
Reader* Case/Strap
CB-1806-B 1 1 1 1
CB-1807-B 1 1 1 1
*: Indicates the card reader can be used on different recorder models.
9
3.4 Specifications
Table 3.2 Specifications
CB-1806-B CB-1807-B
Dimensions 103mm×76mm×31mm
Weight 180g(without batteries)
Carrying case A.B.S plastic
Battery 2 “AA” size Alkaline battery
Power <3VA
Recording time 1day (1,2 optional)
Storage medium SD card
Operation
LCD and Three Keys
method
Communication / Bluetooth
Memory size 1GB or larger
work style Continuous
Indicating range 0mmHg~300mmHg
Pressure
≤3mmHg
precision
Range of blood
Systolic:50mmHg~255mmHg,Diastolic:30mmHg~200mmHg
pressure
Range of pulse 30~200BPM
Recorder have ability to record ECG signal when a pacemaker
Pace record
installed
Temperature 5 - 45°C
Operation
Relative humidity 10 - 95%
environment
Atmospheric pressure 80 - 106kPa
Transport and Temperature：-20°C ~55°C

storage Relative humidity：10% ~ 80%，Non-condensing
environment
Atmospheric pressure 50 - 106kPa; No corrosive
10
4 PREPARATION FOR RECORDING
4.1 Batteries
Place two "AA" alkaline batteries for the BP recorder. Please ensure that the batteries are
placed correctly for proper recorder operation, although installation problem may not damage
the recorder.
To ensure the recorder works for a full recording period, please always use new alkaline
batteries for each new recording. When the recorder is not in use, the batteries need to be
removed out of the recorder.
Note: When rechargeable batteries are to be used, each battery should have the mAh value
higher than 1600; the diameter of the battery should have the same diameter as that of an AA
alkaline battery.
4.2 SD Card
The SD card is the only storage medium for the recorder. When the recording process is
finished, the data recorded in the SD card can be loaded to PC and analyzed by the analysis
software.
4.2.1 Warnings
Please use the SD card coming with the recorder. Using a different brand of SD Card could
cause the compatibility issue or data loss. If you need to add or change SD card, please
contact the manufacturer or distributor.
SD card is very light and precise equipment, so please avoid hitting and bending it. Even
though it is not in use, please keep it in the recorder to avoid losing and material getting stuck
inside the recorder's SD card slot.
The SD card should not be used for other purposes, so as not to avoid damage.
The recorder can supports SD card with the capacity up to 4G.
4.2.2 SD Card Operation
1) Insert SD card: insert gently the SD card as shown in Fig.4.1. Users can feel an elastic
resistance during the inserting.
When inserting the SD card, do not use too much strength. In case of high
resistance, check the inserting direction, and whether the card slot is clogged.
11
2) Remove SD card: Push SD card gently towards the card slot bottom with your finger. The
SD card will automatically pop out after releasing the finger, and then will be removed
easily.
Do not pull the SD card out forcibly to avoid card and recorder damage. The card
will be ejected automatically after pushing inwards. If it does not, please contact
the distributor for further assistant.
Fig.4.1 SD Card inside the battery compartment
4.2.3 Memory Card Formatting
Recorders only support FAT and FAT32 file system, and will not work with other file systems.
If the SD card formatting on the recorder keeps giving errors, such as “Erase Card Error" or
"ACTV Card Failed". Please try the formatting process on a computer. The steps of SD card
formatting operation in Windows systems are given as follows:
1) Insert SD card into the card reader and then attach it to a USB port, and select card
reader in "My Computer". If the SD card has been used for recording ECG data, it will be
shown as "BIOXCO (E :)" (See Fig.4.2 (a)); otherwise, it will be shown as "Removable
Disk (E)", (see Fig. 4.2(b)).
Note: The disk symbol for SD card could vary on different computer.
(a) (b)
Fig.4.2 Drive name of SD Card
2) Right click “BIOXCO (E :)” and then select "Format" (see Fig.4.3 (a)). And then select a
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"File system" for SD card (see Fig 4.3(b)) by following the given criteria, and leave other
parameter as default. Then click “Start”.
 Choose file system "FAT" if the memory card capacity is less than 2G;
 Choose file system "FAT32" if the memory card capacity is larger than 2G.
(a) (b)
Fig. 4.3 SD card formatting
3) A warning message (Fig. 4.4) will appear. Click "OK" to start formatting the SD card.
Fig.4.4 The warning message for SD card formatting
4) Please wait until the formatting process finishes (see Fig. 4.5(a)). Upon completion, click
“OK” on the "Format Complete" message window (see Fig. 4.5 (b)).
5) Right click the SD card drive, and then select "Eject" from the menu as shown in Fig.4.5(c).
Remove the SD card to complete the formatting process.
If the SD card is still not working, please contact the distributor.
13
(a) (b) (c)

Fig. 4.5 Formatting process for the SD card
4.3 Cuff Preparation for Blood Pressure Measurement
Choose a cuff size appropriate to the patient’s arm. Cuff size guidance is given as follows:
 Small fits 17 - 26 cm (6¾ - 10 in.);
 Standard 24- 32 cm (9 ½ – 12½ in.);
 Large 32 - 42 cm (12½ – 16½ in.)
Use a cuff with an incorrect size or replace any components inside the supplied cuff
with ones from different manufacturers might result in measurement bias.
The cuff should be kept around the patient’s upper arm with its bottom edge 1 - 2 cm (about
½ in.) above the elbow position. Wrap the cuff around the arm while giving enough room to be
able to insert one finger into the cuff. Make sure the ART arrow is aligned with the brachial
artery (See Fig.4.6).
Fig. 4.6
14
The cuff could be wrapped around clothing, provided the shirt is thin. Reduce the amount of
wrinkles as much as possible to prevent skin irritation. Place the tubing around the back of
the neck and then down to the recorder.
15
5 OPERATION OF RECORDER
5.1 General Info about Recorder Interface and Operation
Buttons: Use “<” or “>” button to change selections or change numbers. Press “OK” button
to confirm the selection.
Status bar: Show the status of recording, including recording duration, and battery status.
The list of icons used is shown below:
: Record time, which indicates the selected recording duration.
: Bluetooth, which indicates the Bluetooth function is supported.
Note: When connecting to a Bluetooth device, please restart the recorder and leave the
recorder at the main menu without any action.
: Time, which indicates the current time.
: Battery, which indicates the current battery level.
LCD Backlight: The backlight will be turned off for power-saving after certain time without
any action. The screen can be activated by pressing “OK” button. This waiting duration
required to enter the screen-off mode can be adjusted in “Recorder settings”.
Unlock: While recording, the buttons will be locked after the recorder screen is turned off.
Certain operation, as indicated on the recorder screen, is required to unlock the button
operation.
5.2 Main Menu Screen
After two batteries are placed into the recorder, the welcome screen will show up immediately,
as shown in Fig 5.1.
16
Fig. 5.1 Fig. 5.2
The welcome screen will hold for about 2 seconds for system initialization, and then the main
menu screen will be shown (Fig 5.2). In the main menu, press “<” or “>” button to switch the
selection among "Start", “Manual BP Test”, "Settings", and "About". Press “OK” to enter the
selected item. Please see Table 5 1 for the detailed description of those four items.
Table 5.1 Main menu items
Start Start recording
Settings Set up parameters and preferences
Display the model, serial number, version,

About battery voltage information, and pressure
calibration
Measure blood pressure once without

Manual BP Test
saving
5.3 Recorder Settings
The “Settings” function is used to view and change parameter setups related to recorder and
recording. Once the “Settings” item is selected, the “Settings” screen will be shown, giving the
options of "Recording Duration", ”BP Test Interval”, “Retest Failed BP”, “ Alarm”, "Brightness",
“LCD Sleep”, “Reset to Defaults” and "Exit”.
Note: Those settings will be saved once set up, even though the recorder is powered off;
unless indicated otherwise.
17
5.3.1 Recording Time
Select “Rec Duration” (only available on enhanced model) and press "OK" to enter the setup
mode. Then press “<” or “>” to change the recording time (Fig 5.3).
Fig 5.3
The default setting of the recorder is 1 Day.
 The recorder time can be set from 1 to 2 Days.
5.3.2 BP Test Interval
Select “BP Test Interval” and press “OK” to enter the setup interface (see Fig. 5.4), which
includes “Morning” (the starting of the daytime), “Night” (the starting of the nighttime), “Day
BP Cycle” (the BP measurement interval in the daytime), “Night BP Cycle” (the BP
measurement interval in the nighttime) and “Exit”.
Fig. 5.4 Fig. 5.5
5.3.3 Retest Failed BP
Select “Retest Failed BP” and press “OK” to enter the setting (Fig. 5.6). It can be set “ON” or
“OFF”. The default setting is ON.
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 When “Retest Failed BP” is set as “ON”, the recorder will automatically try one more
time after 30 seconds if the blood pressure fails.
 When “Retest Failed BP” is set as “OFF”, the recorder will not automatically try one
more time if the blood pressure fails.
Fig. 5.6
5.3.4 Alarm
Select “Alarm” and press “OK” to enter the alarm setting (see Fig. 5.7). It can be set “OFF” or
“Once”. The default setting is OFF.
Fig. 5.7
 When “Once” is set, the recorder will alarm once if abnormal pressure is detected
during the daytime.
 When “OFF” is set, no alarm will be triggered.
Note: “Alarm” will be reset to “OFF” once the recorder is powered off.
5.3.5 Brightness
Select “Brightness” and press "OK" to enter the setup mode. Then press “<” or “>” to change
the brightness (5 levels in total).The default setting of brightness is 1.
19
5.3.6 LCD Sleep
Select “LCD Sleep” and press "OK" to enter the setup mode. Press “<” or “>” to change the
waiting time for LCD sleep to 10s, 15s, 20s, 25s or 30s.The default setting of LCD sleep time
is 15s.
5.3.7 Date and Time Setup
Select “Date and time” and press “OK” to set up Date and time (Fig 5.8). In setting interface,
press “<” or “>” to switch among year, month, day, hour and minute. Press "OK" to enter the
number-changing mode, and then press “<” or “>” to change the number. Press "OK" again to
confirm the change.
Fig 5.8
Note: The date setting will be adjusted for leap year automatically.
After setting up correct date and time, select “Save&Exit” to save settings or select “Cancel”
to discard changes and return to recorder settings.
5.3.8 Reset to Factory Settings
Select “Reset to Defaults” and press “OK” to restore the recorder to default status.
5.3.9 Exit Recorder Settings
Select “Exit” and press "OK" to exit. All settings will be saved (Fig. 5.9) and it will return to
main menu as shown in Fig 5.2.
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Fig 5.9
5.4 Recording Parameter Settings with ARCS
The recording settings for the 1806/1807 Recorders can also be set up through a SD card or
Bluetooth using the "ARCS Series Analysis and Reporting Software "which is installed on a
computer.
Settings in the “ARCS” are given as follows:
 Recording time setting: set the recording time of the recorder
o Standard Recorder: one day maximally
o Enhanced Recorder: two days maximally
 BP Test Interval: set up the starting time and the ambulatory BP monitoring intervals
for nighttime and daytime, respectively
 Auto-triggered BP measurement: BP measurement will be automatically started when

heart rate is out of the preset normal range or ST level is lower than the preset normal
range.
 Estimation systolic pressure: used for setting the target inflation pressure for the first
BP measurement. The suggest value should be the systolic pressure from the regular
BP measurement plus 30 mmHg.
 Date and time: the clock in the recorder is automatically synced with that on PC when
Bluetooth is used for communication. This feature is only available for 1807.
 Patient information: Patient’s demographic information
Note: Please refer to the User Manual for “ARCS Series Analysis, Reporting and
Communication” software for details.
21
5.5 Wireless Communication
Wireless communication with Bluetooth technology is available for 1807 model. The recorder
is able to communicate real-time with PC wireless on certain to transfer certain data. The
recorder needs to stay on main menu screen for building connection with a Bluetooth adapter
(Fig 5.10).
Fig. 5.10
Run "ARCS Series ECG and ABP Analysis and Reporting Software" on PC for setting up
recording parameter setup. Refer to ARCS software user manual for details.
5.6 About Recorder
“About Recorder” function is used to display the general information about the recorder and
check the pressure sensor. Select “About” in main menu as shown in Fig 5.2 and press "OK"
(see Fig. 5.11).
Fig. 5.11
Select “About” and press “OK” to see the detailed information about the recorder, including
model number, serial number, firmware version and battery voltage information (Fig. 5.12).
22
Fig. 5.12
Select “Check Pressure” in Fig. 5.11 and press “OK” to check whether the pressure sensor
works properly with a pressure calibration device. If there is no air pumped into the recorder,
it will show 000 mmHg; if there is air pumped into the recorder, it will show the current
pressure xxx mmHg, which will be with the acceptable error range (±1 mmHg) if pressure
sensor works properly.
Fig. 5.13
5.7 Blood Pressure Measurement
In the main menu screen, select “Manual BP Test” and press “OK” to have a regular blood
pressure measurement as shown in Fig. 5.14. All the measurements will not be stored either
on the recorder or on the SD card. The systolic pressure obtained here can be used for
setting the target inflation pressure by adding 10 mmHg to it (180 mmHg in Fig. 5.14). After
measurement, it will show and keep the result(see Fig 4.15), till you click OK, it will exit and
return to the main interface.The measurement can be cancelled by pressing “OK” during
testing (see Fig. 5.16).
Note: For safety purpose, two consecutive blood pressure measurements within 30 seconds
are not allowed.
23
Fig. 5.14 Fig. 5.15
Fig. 5.16
5.8 Start Recording
In the main menu screen (Fig. 5.2), select “Start” and press "OK" to enter the interface for
showing the recording summary information will be shown (Fig. 5.17).
Fig. 5.17
Note: If the recordings parameters are set up via Bluetooth, the recorder will automatically
directly start the recording.
In the recording summary information screen (Fig. 5.17), select “OK” and press "OK" to
following SD card formatting step (Fig 5.18(b)).
If the formatting processing fails, an error message of “Check SD Card” will be shown (Fig.
5.18(a)). Please refer to Section 4.2.3 if formatting on the device has been tried a few times
24
and still fails.
(a) (b)
Fig.5.18
The recorder will start recording after everything is set up correctly. The recording interface
as Fig. 5.19 will be shown.
Fig. 5.19
During recording, press “OK” to bring up the menu as shown in Fig. 5.20(a). A BP
measurement can be started immediately by selecting “Start BP Test” (Fig. 5.20(b)). During
the BP measurement, press “OK” to cancel it (Fig. 5.20(c)). Ambulatory BP measurement
data can be reviewed by entering “BP Test History” (Fig. 5.20(d)). BP measurement can be
temporarily disabled by setting “Disable BP Test”.
Note: For different recording modes, only appropriate options are displayed.
(a) (b)
25
(c) (d)
Fig. 5.20
During the recording, if the battery runs low for BP measurements, the recording will be
disable the BP measurement function first (Fig. 5.21(b)). If a regular BP measurement is tried,
the measurement will not be started and the message, “BP Stopped” will be shown (Fig.
5.21(c)). If the battery runs low for record, the message, "Rec. Stopped", will be displayed
(Fig. 5.21(a)).
(a) (b) (c)
Fig.5.21
5.9 Keypad Unlocking
The screen will be locked if there is not any action for 15 seconds during the recording. The
recorder will not be operated when screen is locked. Press “OK” to light the screen and then
press”>” to unlock (Fig. 5.22).
26
Fig.5.22
5.10 Recording Finished
When the record process is finished, the message of “Recording Finished” as will be shown
(Fig. 5.23). Remove the battery and SD card out of recorder. Use "ARCS Series Analysis and
Reporting Software" to receive and analyze data on the SD card.
Note: Please refer to “ARCS” User manual for the details about loading and analyzing data
with ARCS on PC.
Fig 5.23
27
6 MAINTENANCE
6.1 General
Repair of BIOX products under warranty must be made only by properly trained service
personnel, who are authorized by BIOX Instruments Co., Ltd.
6.2 Cleaning of Recorder and Accessories
Clean the device surface with a damp cloth, making sure that no fluid gets into the device.
Accessories, such as BP Cuff, can be disinfected with mild disinfectant solution.
6.3 Storing
The recorder should have no battery inside while not in use, and should be stored in a dry
indoor space containing no corrosive substances.
6.4 Calibration
Recorder should be calibrated for its BP performance once every two years. The procedures
are given below.
 Pressure from 0 to 300 mmHg is generated by a standard calibration device and then
input into the recorder. Compare the readings from the recorder and those from the
calibration device. Please contact the distributor if big reading discrepancies (> 3
mmHg) are found.
6.5 Disposal
Used batteries and other hardware parts should be disposed in accordance with relevant
local laws and regulations governing medical disposals.
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7 TROUBLESHOOTING
7.1 Recording Time Less Than 1 Day
1) Possible causes and solutions

Causes Solutions
Battery is taken out during recording Keep battery in the recorder during recording
Recorder suffers strong vibration Avoid strong vibration while recording.
A low-quality or used batteries is used Use a new qualified alkaline battery
The recorder is defected Contact the distributor for repair
Avoid the usage of the recorder in a strong
Electromagnetic interference
electromagnetic environment.
2) Confirmation method for the issue caused by battery

Run "ARCS Series Analysis, Reporting and Communication Software", and choose the
patient case having partial recording. Click "Maintenance–>Voltage" to view the battery
voltage curve as shown in Fig. 7.1. Please see the user manual of “ARCS” for more details.
 If the "Min Voltage" is less than 1.6 V, it can be determined that the battery power has
shortage. That is possibly caused by using a low quality battery or a used battery.
 If the curve ends before 24 hours, it can be determined that the battery loses
connection with the recorder or recorder failure.
Fig.7.1 Battery voltage trend curve
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7.2 Memory Card Issues
1) Possible causes and solutions

Issues Causes Solution
A memory card is not inserted. Insert a memory card
The file system of the memory Format the memory card on a
card is not correct. PC with a correct file system.
Contact the distributor for
Recorder displays Defected recorder
repair
“Check SD Card!”
The memory card is broken Use a new memory card
The recorder is powered off
Format the memory card on a
when the ”erasing memory card”
PC
operation is not completed
The PC operating systems
Take out the memory card and
sometimes need a long time to
insert it back to card reader
recognize a memory card.
PC can’t recognize
The card reader is broken Use a new card reader
the memory card
Bad USB port or unstable power Insert card reader into another
supply USB port
Memory card is formatted Format memory again and
incorrectly have a new recording
7.3 BP Measurement Issues

Adjust the air tube to the BP
The air tube is blocked cuff. If the problem persists,
No deflation or slow contact the distributor.
deflation of BP cuff
Malfunction of air path inside
Contact the distributor.
recorder.
No inflation of BP cuff
or not enough BP cuff is leaking. Change the cuff
pressure
30
Change the cuff, or contact the

BP cuff is leaking; Low battery distributor; Change battery;
The BP results have voltage; over-exercise right
big deviation before recording. Take a rest before the patient
has a test.
7.4 Bluetooth Communication Issues

Driver is not properly
Re-install the driver
installed or computer
Recorder error Contact the distributor for repair
PC parameters The connection between
setup error Bluetooth adaptor and PC Reconnect the adapter to PC
is not stable good
Defective Bluetooth
contact the distributor for repair
adaptor
31
7.5 Real Time Clock
1) The cause of the issue and solutions

After powered
on, if the status
of the real time
clock in the
standby main
interface is in
yellow and 1. Enter setup interface in the
Keep flashing, standby status, and set the
select start clock. Set the time to the
recording, it A clock chip failure current time, save and exit. It
cannot record can complete the recording
after click the when powered on.
central button, 2. Contac the distributor, and get
the interface fixed.
prompts
“Rtc Err ， To
Continue ，
Please Back
and set Clock”
32
8 REFERENCE TO STANDARDS
8.1 International Standards
IEC 60601-1 Medical electrical equipment–Part 1: General requirements for basic safety and
essential performance,
IEC 60601-1-2 Medical electrical equipment Electromagnetic compatibility,
ISO 10993 Biological evaluation of medical devices–Part 1: Evaluation and testing
MDD 93/42EEC
8.2 EMC Information

Table 8.1 Guidance and manufacturer’s declaration – electromagnetic emissions
The recorder is intended for use in the electromagnetic environment specified below, which
should be assured during usage.
Emissions test Compliance Electromagnetic environment – guidance
The recorder only uses RF energy for its internal
RF emissions Group 1 function. Therefore, its RF emissions are very low and
CISPR 11 Class B are not likely to cause any interference in nearby
electronic equipment.
RF emissions Group 1
CISPR 11 Class B The recorder could be directly connected to the public
low-voltage power supply network.
Harmonic
emissions Not Warning: The recorder is intended for use by
applicable healthcare professionals only. The recorder may
IEC 61000-3-2
cause radio interference, disrupting the operation of
Voltage nearby equipment. It may be necessary to take
fluctuations/flicker Not mitigation measures, such as re-orienting or
emissions applicable relocating the recorder or shielding the location.
IEC 61000-3-3
33
Table 8.2 Guidance and manufacturer’s declaration – electromagnetic immunity
The recorder is intended for use in the electromagnetic environment specified below, which
should be assured during usage
Complian Electromagnetic environment
Immunity test IEC 60601 test level
ce level –guidance
Electrostatic ±6 kV Floors should be wood, concrete

±6 kV Contact
Contact or ceramic tile made. If floors are
discharge ±8 kV air covered with synthetic material,
(ESD)IEC ±8 kV air
the relative humidity should be at
61000-4-2 least 30 %.
±2 kV for power
Electrical fast
supply lines Not
transient/burst Not applicable
±1 kV for input/output applicable
IEC 61000-4-4
lines
Surge ±1 kV lines to lines Not
Not applicable
IEC 61000-4-5 ±2 kV lines to earth applicable
<5 % UT* (>95 % dip

Voltage dips,
in UT) for 0,5 cycle
short
interruptions and 40 % UT (60 % dip in
voltage UT) for 5 cycles Not
variations on Not applicable
70 % UT (30 % dip in applicable
power supply UT) for 25 cycles
input lines
<5 % UT (>95 % dip
IEC 6100-4-11 in UT) for 5 sec
Power frequency Power frequency magnetic fields
(50/60 Hz) should be used at a typical
magnetic field 3A/m 3A/m
location, such as a typical
IEC 61000-4-8 commercial area or hospital.
Portable and mobile RF

communications equipment
3V/m
should be used no closer to any
Radiated RF 3V/m 80MHz part of the CARDIOCARE PRO3
IEC 61000-4-3 80MHz～2.5GHz ～ or CARDIOCARE PRO12,
2.5GHz including cables, than the
recommended separation
distance calculated from the
34
equation applicable to the

frequency of the transmitter.
Recommended separation
distance
d=1.2 P 80MHz~800MHz
d=2.3 P 800MHz~1000MHz
Where P is the maximum output

power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in metres(m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
should be less than the
compliance level in each
frequency range.
Interference may occur in the
vicinity of equipment
marked with the following symbol:
Conducted RF 3Vrms Not Not applicable

applicable
IEC 61000-4-6 150kHz～80MHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Recorder is used
exceeds the applicable RF compliance level above, the Recorder should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the recorder.
35
Table 8.3 Recommended separation distances between portable and mobile RF

communications equipment and the recorder.
The recorder is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Recorder can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the Recorder as recommended
below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter/m
Rated
maximum 150kHz~80MHz 80MHz~800MHz 800MHz~1000MHz
output power of
transmitter/W d=1.2 P d=1.2 P d=2.3 P
0.01 Not applicable 0.12 0.23

0.1 Not applicable 0.38 0.73
1 Not applicable 1.2 2.3
10 Not applicable 10 7.3
100 Not applicable 100 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
36
9 CONTACT INFORMATION
Factory:
BIOX Instruments CO., Ltd.
(A Vasomedical Company)
100 Dicui Road 530 Building 1,19th Floor BinHu District,
Wuxi,Jiangsu 214072,P.R.C
Telephone: 86-510-85884900, 86-510-85810163
Fax: 86-510-85864443
Email: support@biox.com.cn, sales@biox.com.cn.
Website: www.biox.com.cn;
OCTOPUS LIMEDIC
Hagemasvagen 10 Octopus Medical AB,
P.O. Box 3035
183 03 Taby, Sweden
Tel: +46 87567110
Fax:+46 87326938
37

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VASOMEDICAL-BIOX 1806/1807 AMBULATORY BP RECORDER USER MANUAL

5.10 Recording Finished ............................................................................................27

1 LIMITED WARRANTY AND TECHNICAL

1.1 Limited Warranty

Vasomedical, Inc. warrants the Vasomedical-BIOX™ 1806/1807 Ambulatory Blood Pressure

1.2 Technical Support and Service

2.1 About This Manual

Document number and version Date Issued

2.2 Intended Use

Vasomedical-BIOX 1806/1807 Ambulatory Blood Pressure Recorder is a non-invasive device

Patients sensitive to electric static discharge (ESD).

2.4 Proper Environmental Conditions

 Patients should be aware to avoid being close to electromagnetic interference sources,

 Do not get too close to TV and car engines.

 Using the recorder with defibrillation and other elector-physiological examination is

 Avoid using electric blankets or heating-water bed for sleep warm-up.

Table 2.2 Symbol list

THIS END UP.

FRAGILE, HANDLE WITH CARE

TEMPERATURE LIMITATION (VALUES STATED AS

< LEFT BUTTON

> RIGHT BUTTON

CONSULT INSTRUCTIONS FOR USE

DISPOSAL OF WASTE ELECTRICAL /

3.2 Recorder Illustration

3.3 Items in a Package

Table 3.1 Standard Accessories

Transport and Temperature：-20°C ~55°C

4 PREPARATION FOR RECORDING

4.2.2 SD Card Operation

Fig.4.1 SD Card inside the battery compartment

4.2.3 Memory Card Formatting

Fig.4.4 The warning message for SD card formatting

If the SD card is still not working, please contact the distributor.

(a) (b) (c)

4.3 Cuff Preparation for Blood Pressure Measurement

5.1 General Info about Recorder Interface and Operation

: Record time, which indicates the selected recording duration.

: Bluetooth, which indicates the Bluetooth function is supported.

: Time, which indicates the current time.

: Battery, which indicates the current battery level.

5.2 Main Menu Screen

Fig. 5.1 Fig. 5.2

Table 5.1 Main menu items

Start Start recording

Settings Set up parameters and preferences

Display the model, serial number, version,

Measure blood pressure once without

5.3 Recorder Settings

5.3.1 Recording Time

The default setting of the recorder is 1 Day.

 The recorder time can be set from 1 to 2 Days.

5.3.2 BP Test Interval

Fig. 5.4 Fig. 5.5

5.3.3 Retest Failed BP

5.3.6 LCD Sleep

5.3.7 Date and Time Setup

5.3.8 Reset to Factory Settings

5.3.9 Exit Recorder Settings

5.4 Recording Parameter Settings with ARCS