DARAY V460S Series Installation and operating instructions

V460S Series
Ambulatory NIBP Patient Monitor with SpO2
User Manual & Installation Guide
QAM.V460S.0915.4

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Contents
1. Introduction.................................................................................... 4
1.1 Supported Units .......................................................................... 4
1.2 Specification.............................................................................. 5
1.3 Pre-Operation Responsibilities and component packing list........................ 7
1.4 Packing List ............................................................................... 7
1.5 Safety Information ....................................................................... 7
2. General Operation Guide Section ........................................................... 9
2.1 Product Layout ..........................................................................10
2.2 Pre-Start Checks ........................................................................11
2.3 Battery Installation .....................................................................11
2.4 Operation, Powering On and Menu Functions .......................................11
2.5 Mode Selection, Modes and Backlighting.............................................12
2.5.1 Standard Measurement Screen (the boot-strap menu)...................... 12
2.5.2 Measuring the ambulatory blood pressure function: ........................ 12
3. Alarm Operation..............................................................................13
4. NIBP Operation ...............................................................................14
4.1 Introduction..............................................................................15
4.2 Considerations and Measurement Limitations.......................................15
4.3 Placement and Operation..............................................................16
4.4 Troubleshooting NIBP Messages and Explanations ..................................18
5. SpO2Operation ...............................................................................19
5.2 Considerations and Limits..............................................................21
5.3 Placement and Operation..............................................................22
5.4 Troubleshooting .........................................................................22
6. Software Operation & .......................................................................23
Initial Set-up Guide Section....................................................................23
6.1 Software Requirements ................................................................24
6.2 Installation of the software............................................................24
6.3 Considerations...........................................................................24
6.4 Introduction to the software ..........................................................24
6.4.1 User registration ................................................................. 24
6.4.2 Patient File Path ................................................................. 25
6.4.3 Main Interface .................................................................... 25
6.4.4 Wearing the Monitor ............................................................. 26
6.4.5 Designing the measurement plan .............................................. 26
6.4.6 Data download ................................................................... 27
6.4.7 Choose patient data to edit .................................................... 28
6.4.8 Delete data file .................................................................. 29
6.4.9 Data file backup.................................................................. 29
6.4.10 Edit Blood pressure data....................................................... 30
6.4.11 Trend Editing.................................................................... 30
6.4.12 SpO2Trend Edit ................................................................. 32
6.4.13 Display the statistics information ............................................ 33
6.4.14 Editing diagnosis information ................................................. 33
6.4.15 Sleep period settings........................................................... 33
6.4.16 Blood Pressure Thresholds..................................................... 34
6.4.17 Histogram Report ............................................................... 34
6.4.18 Pie Chart Reports ............................................................... 35
6.4.19 Correlation lines ................................................................ 35
6.4.20 Report Printing.................................................................. 36
6.4.21 Help .............................................................................. 36

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7. First Time Setup and the on-board menu functions .....................................37
7.1 Introduction..............................................................................38
7.2 Main Interface ...........................................................................38
7.3 System Menu.............................................................................38
7.4 System Setup ............................................................................39
7.5 BP SETUP .................................................................................40
7.6 SpO2SETUP...............................................................................40
7.7 Patient Information.....................................................................41
7.8 BP TABLE .................................................................................41
7.9 SpO2TABLE...............................................................................41
7.10 TREND ...................................................................................42
8. Maintenance ..................................................................................43
8.1 Maintenance schedule ..................................................................43
8.2 Safety Precautions ......................................................................43
8.3 Cleaning ..................................................................................44
8.4 Restrictions ..............................................................................44
8.4 Disposal...................................................................................45
8.5 Transportation and Storage............................................................45
9. Troubleshooting Guide ......................................................................46
10. Replacement Parts .........................................................................47
11. Warranty Information ......................................................................48
11.1 Returns Policy ..........................................................................48
11.2 Warranty Details .......................................................................49

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1. Introduction
Thank you for choosing a Daray V460S Ambulatory NIBP Patient Monitor with SpO2.
The V460S monitor is specifically designed to meet the demanding needs of today’s
medical department whilst providing the finest quality design with superior
performance, reliability and value.
The V460S not only measures parameters, it also records them; it integrates
parameter measuring modules into its functions and also allows you to display and
review data from the device.
This user guide has been provided to give detailed descriptions covering the
performance, operation and safety information of the device.
It is recommended that users read through this document before using the device so
they are aware of its complete and proper operation. This includes its features and
optional fixings and is to ensure users are able to operate the monitor appropriately
whilst also ensuring patient and operator safety.
Restrictions and Liabilities
Information in this document is subject to change and does not represent a
commitment by DARAY. Changes made to the information in this document will be
incorporated in new editions of the publication. No responsibility is assumed by DARAY
for the use or reliability of software or equipment that is not supplied by DARAY.
For further information on our product range and find out more about our company
please visit www.daray.co.uk or call 0333 321 0971
This product was designed & manufactured in Great Britain by:
Daray Ltd.
Marquis Drive, Moira
Swadlincote
Derbyshire
DE12 6EJ
1.1 Supported Units
The Following Models are supported in this Manual
V460S
Handheld Ambulatory Patient
Monitor with SpO2

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1.2 Specification
General Information
Display
2.4 inch colour LCD Display (V460S - 64k Colour OLED)
Measuring Parameters
Blood Pressure, PR, Pulse strength/waveform, (V460S - SpO2)
Battery
2 x AA Battery’s and low battery indicators
Alarms
0-100% Adjustable
Data
24 Hour monitoring with automatic power-off function
Connection
Mini USB
Backlight
Yes
Dimensions
63 (H) x 34 (W) x 33 (D) mm
Net Weight
350g (with batteries)
Working Voltage
2.2V DC ~ 3.4 V DC
Power Supply
3 (V) DC Pmax = 2.56VA
Specification
Measurement Method:
Oscillometric
Mode:
Manual, Auto, STAT
Measuring Type:
Systolic (SYS), Diastolic (DIA), Mean (MAP)
Measuring Unit:
mmHg / KPa selectable
Patient Range:
Adult, Paediatric, Neonatal
Over Pressure Protection:
Yes
Cuff Pressure Range
Meets ANSI/AAMI SP10-1992
Pulse Rate Range
30-220
Over Pressure Protection
Independent safety microprocessor monitors cuff pressure,
measurement time as well as the operation of the main
microprocessor
The SYSTOLIC and DIASTOLIC values measured using this device shall be equal to those
measured by trained medical personnel using cuff and stethoscope. The MEAN value measured
using this device is equal to that measured using a blood pressure measurement device.
Blood Pressure Measurement Ranges
Adult
SYS
40-270mmHg
MAP
30-235mmHg
DIA
20-215mmHg
Paediatric
SYS
40-200mmHg
MAP
30-165mmHg
DIA
20-150mmHg
Neonatal
SYS
40-135mmHg
MAP
30-110mmHg
DIA
20-100mmHg
Maximum mean error of measurement:
±5mmHg
Maximum experimental standard
deviation:
8mmHg
Pressure Resolution:
1 mmHg
SpO2 Monitoring (V460S only)
Patient Type
Adult, Paediatric, Neonatal
Range
35 ~ 99%
Resolution
1%
Accuracy
±2% (90%~00%), ±3 % (70%~9%)
Alarm Range
0-100%

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Pulse Rate (V460S only)
Storage and Review
Maximum Data Quantity:
300 records of common user data and 358 Ambulatory BP data
Every record includes the detailed measure time, systolic blood
pressure, diastolic blood pressure, mean blood pressure, pulse
rate, error message and record number, etc.
Operating Environment
Temperature:
5～40 (C) (V460S - 0～40 (C))
Transport and storage
Temperature:
-20～60 (C)
Humidity (noncondensing):
≤ 80 % (V460S –15% ~ 95%)
Transport and Storage Hum
≤ 95 % (V460S –10% ~ 95%)
Altitude:
-500 to 4,600m (-1,600 to 15,000ft) 86 ~ 106 KPa
Transport and Storage Alt
-500 to 13,100m (-1,600 to 43,000ft) 50 ~ 106 KPa
This device has a user friendly operation interface. It integrates data review functions and display
functions which include a large-print single record data review, data list, BP data trends chart,
the current time, data, power, alarm, etc.
Users can power on/off the monitor, start manual measurements, set system parameters, etc.
with the five keys on the front panel. (Please refer to section 1.2 for details).
There are light and sound alarm functions where the audio alarm intermittently beeps and a built
in red light will flash. When a measurement result exceeds the alarm limits, the colour of the
measured result becomes red and an alarm sounds. The user can turn on or off the alarm sound if
necessary.
The cuff socket is located on the top of the device and the USB socket at the bottom of the
device. The stored data can be transferred to a computer via the USB interface, and then various
operations can be performed by using the PC software. (Please refer to "Software Functions"
section for detailed contents)
In the ambulatory measurement mode, the monitor can work for up to 24 hours continuously.
The monitor has the capability of recording up to 4800 measurements, along with displaying a
BP data trends chart.
Measurement Performance in a Weak Filling Condition
A weak filling condition during a measurement will impact the monitor’s performance to some
degree. However, the SpO2and pulse rate can be shown correctly with a pulse filling ratio of
0.4%. During a weak filling measurement the SpO2error is ±4% and the pulse rate error is ±2bpm.
This device is defibrillator protected. Note that no precautions specific to the
device are required during defibrillation, and defibrillation discharge has no effect on the
monitor. The equipment uses a gray silicone airway as a precaution for when a
defibrillation device is used on the patient, this is to protect the equipment from the
effect.
This monitor complies with EN1060 Part 1: General requirements; Part 3: Supplementary
requirements for electro-mechanical blood pressure measuring systems (in course of preparation).
Range
0 ~ 250 bpm
Resolution
1 bpm
Accuracy
±2 bpm

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1.3 Pre-Operation Responsibilities and component packing list
This document is a guide to the steps that need to be performed to correctly operate the V460S
Series Ambulatory patient monitor system. However, any work required for the setup or operation
of the device is the responsibility of the owner or designated operators.
1.4 Packing List
The components supplied by Daray should be the following items in the specified quantities,
unless otherwise arranged.
V500 Packing List
Qty.
V460 Ambulatory Patient Monitor
1
Adult SpO2Finger Sensor
1
Adult NIBP Cuff
1
Carry Case
1
PC Software CD
1
USB cable
1
User Manual
1
Please be aware using un-approved accessories may cause damage to the device.
Please contact Daray for any further information.
1.5 Safety Information
The safety statements presented in this chapter refer to the basic safety information that the
operator of the monitor should pay attention to and abide by. This information may be repeated
within subsequent sections to reiterate our warnings, some sections may also have warnings for
specific operational aspects.
Warnings and Cautions are used throughout this manual to point out hazards and to designate a
degree or level of seriousness, these should be observed at all times and include electrical safety
warnings.
These warnings are used to indicate a potential hazard situation or unsafe practice that, if not
avoided, could result in death or serious injury.
Cautionary notices are used to indicate a potential hazard or unsafe practice that, if not avoided,
could result in minor personal injury or product/property damage.
Considerations
Pre-use
To ensure patient and user safety, its recommended that the device and
its accessories are regularly checked for damage and normal operation
before use; if any damage is found you should immediately stop using
the device and contact your relevant body.
Usage
This monitor is intended only as an adjunct in patient assessment. It
must be used in conjunction with clinical signs and symptoms. It is not
intended as a device used for treatment purposes. This device should
only ever be used on one patient at a time.
Warning: If Luer lock connectors are used in the construction of
tubing, there is a possibility that they might be inadvertently
connected to intravascular fluid systems, allowing air to be pumped
into a blood vessel.
Do not pull or lift the monitor by its connection cables. This may cause
damage to the leads or the stability of the device leading to subsequent
patient injuries
Do not use the monitor when wet, for any internal water damage please
contact daray.

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Please ensure any connecting hardware such as PC’s meet appropriate
compliance requirements for IEC 60950.
The software was developed per IEC60601-1-4. The possibility of hazards
arising from errors in the software program are minimal
Users
This monitor is intended for use only by appropriately trained or
instructed personnel.
Monitoring
Limitations
Ensure that the environment in which the device is operated is not
subject to any sources of strong electromagnetic interference, such as
radio transmitters, mobile telephones, etc. Keep them far away. High
level electromagnetic radiation emitted from such devices may greatly
affect the instrument performance.
When using the monitor in conjunction with electrical surgery
equipment, the user should pay attention to and guarantee safety of the
patient being monitored.
You should refrain from using mobile phones in close proximity to the
monitor as mobiles could cause electromagnetic interference with the
monitor.
Ambulatory Use
and Patient
Movement
Please do not hang the monitor in any way whilst transporting the
patient. The potential for the monitor to swing could cause physical
damage to the patient or the monitor. For information on Mounting
options please contact daray
EXPLOSION
HAZARD
Possible explosion hazard if used in the presence of flammable
anaesthetics or other flammable substances in combination with air,
oxygen-enriched environments, or nitrous oxide.
Transportation and
Storage
Improper storage or transport of the monitor and its accessories can
cause contamination, Please use the recommended cleaning and
disinfecting methods as indicated in this manual before use.
Maintenance
Do not touch, or rub the display screen with abrasive cleaning
compounds, instruments, brushes, rough surfaced materials or make
contact with anything that can scratch the panel. For detailed cleaning
instructions please refer to the maintenance section of this manual.
The Monitor is a Sealed device, however, do not submerge in any liquids
and keep the monitor placed appropriately when in use or storage to
prevent any potential damage from falling, persistent strong vibrations
or other mechanical damage.
Any internal maintenance should only be conducted by a Daray
authorised service centre. For further details please contact Daray.
Standard electrical safety tests should be conducted once every 12
months by qualified personnel
Disposal
Please dispose of the packaging material, observing the applicable
waste control regulations and keeping it out of children’s reach.
At the end of its service life, the product described in this manual, as
well as its accessories, must be disposed of in compliance with the local
governing guidelines regulating the disposal of such products. If you
have questions concerning disposal of the product, please contact one
of your local government representatives.

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2. General Operation Guide Section