North-Vision Tech Deluxe-80 User manual

User Manual for Multi-parameter Patient Monitor North-vision Tech. Inc.
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Multi-parameter Patient Monitor
Deluxe-80
User Manual
Version: 1.5
Issued by: Sara Lo Date: 5/11/2020
Reviewed by: Albert Huang Date: 5/11/2020
Document No: UM-PM8-201507-01
North-Vision Tech. Inc.
2460

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This Manual is written and compiled in accordance with the IEC 60601-1（Medical electrical equipment
Part1: General requirements for safety）and MDD 93/42/EEC. It complies with both international and
enterprise standards and is also approved by the Food and Drug Administration, Ministry of Health and
Welfare. The Manual is written for the current Deluxe-80 Multi-Parameter Patient Monitor.
The Manual describes, in accordance with the Vital Signs Monitor’s features and requirements, main
structure, functions, specifications, correct methods for transportation, installation, usage, operation, repair,
maintenance and storage, etc. as well as the safety procedures to protect both the user and equipment. Refer
to the respective chapters for details.
The Manual is published in English and we have the ultimate right to explain the Manual.
Marks in the Manual:
Warnings: must be followed to avoid endangering the operator and the patient.
Notes: contains some important information and tips about operations and application.
Attentions: must be followed to avoid causing damage to the monitor.

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Instructions to User
Dear Users,
Thank you very much for purchasing our product. Please read the following information very carefully
before using this device.
Read these instructions carefully before using this monitor. These instructions describe the operating
procedures to be followed strictly. Failure to follow these instructions can cause monitoring abnormity,
equipment damage and personal injury. The manufacturer is NOT responsible for the safety, reliability
and performance issues and any monitoring abnormality, personal injury and equipment damage due
to user’s negligence of the operation instructions. The manufacturer’s warranty service does not cover
such faults.
Do NOT operate this monitor in the circumstance where flammable gas or explosion factor
exists.
To ensure patient safety, do NOT place the monitor in any position that might cause it to fall
on patient.
The user must check that the equipment functions safely and ensure that it is in proper
working condition before being used.
The device connected to this monitor should be in accordance with IEC 60601-1.
Please shut down the monitor and remove sensors while during MRI scanning, or else induced
current could potentially cause burns. The monitor may affect the MRI image, and the MRI
unit may affect the accuracy of monitor measurements.
Although biocompatibility tests have been performed on all the applied parts, some
exceptional allergic patients may still have anaphylaxis. Do NOT apply to those who suffer
from anaphylaxis.
All the cables and rubber tubes of the applied parts should be kept away from the patient’s
cervix to prevent any possible suffocation of the patient.
All the parts of the monitor should NOT be replaced at will. If necessary, please use the
components provided by the manufacturer or those of the same model and standards as the
accessories along with the monitor which are provided by the same factory, otherwise
negative effects concerning safety and biocompatibility, etc. may be caused.
If the monitor falls off accidentally, please do NOT operate it until its safety and technical
indexes have been carefully tested and positive testing results obtained.
Before maintenance, please switch off power.
This monitor is a professional medical device, can only be operated by trained personnel with
qualification.
Please peruse the relative content about the clinical restrictions and contraindication.
Dispose of the expired device and its accessory according to applicable local regulations.

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Table of Contents
CHAPTER 1 OVERVIEW 6
1.1 FEATURES 6
1.2 PRODUCT NAME AND MODEL 6
1.3 INTENDED USE 6
1.4 NORMAL WORKING ENVIRONMENT 6
1.5 SYMBOLS ON THE MONITOR 7
CHAPTER 2 OPERATING PRINCIPLE 8
2.1 CONFORMATION 8
2.2 OVERALL STRUCTURE 8
CHAPTER 3 INSTALLATION AND CONNECTION 9
3.1 APPEARANCE 9
3.1.1 Front Panel 9
3.1.2 Side Panel 11
3.1.3 Rear Panel 11
3.2 INSTALLATION 12
3.2.1 Opening the Package and Check 12
3.2.2 Connecting the Power Supply 12
3.2.3 Starting the Monitor 13
3.3 SENSOR PLACEMENT AND CONNECTION 13
3.3.1 Blood Pressure Cuff Connection 13
3.3.2 SpO2Sensor Connection 14
3.3.3 Loading printing paper 15
3.3.4 Battery Installation 16
CHAPTER 4 OPERATIONS 18
4.1 INITIAL MONITORING SCREEN 18
4.1.1 Screen Description 18
4.1.2 Operation Instructions 19
4.2 SPO2TREND GRAPH DISPLAY 20
4.3 NIBP LIST SCREEN 21
4.3.1 Operation Instructions 21
4.4 SETUP MENU SCREEN 22
4.4.1 SpO2Setup 22
4.4.2 NIBP Setup 23
4.4.3 Nurse Call 24
4.4.4 System Setup 25
4.4.5 Patient Info 26
4.4.6 Date/Time 26
4.4.7 Recover Default Settings 26
4.5 POWER SAVING MODE 27
CHAPTER 5 TECHNICAL SPECIFICATIONS 28
5.1 NIBP MONITORING 28
5.2 SPO2MONITORING AND PULSE RATE MONITORING 28
5.3 PULSE RATE MONITORING 28
5.4 RECORDER 28
5.5 OTHER TECHNICAL SPECIFICATIONS 28
CHAPTER 6 PACKAGING AND ACCESSORIES 30

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6.1 PACKAGING 30
6.2 ACCESSORIES 30
CHAPTER 7 WORKING PRINCIPLE 31
7.1 THE PRINCIPLE OF NIBP MEASUREMENT 31
7.2 POINTS TO BE NOTED IN NIBP MEASUREMENT 31
7.2.1 Operation instructions 31
7.2.2 Clinical Limitations 32
7.3 THE PRINCIPLE OF SPO2/PULSE MEASUREMENT 32
7.3.1 Working Principle 32
7.3.2 Points to be noted in SpO2and Pulse Measuring 32
7.3.3 Clinical Limitations 33
CHAPTER 8 TROUBLESHOOTING 34
8.1 NO DISPLAY ON THE SCREEN 34
8.2 NO BLOOD PRESSURE AND PULSE OXYGEN MEASURES 34
8.3 SYSTEM ALARM 34
CHAPTER 9 MAINTENANCE 35
9.1 SERVICE AND EXAMINATION 35
9.1.1 Daily Examination 35
9.1.2 Routine Maintenance 35
9.1.3 Battery Maintenance 35
9.2 CLEANING,STERILIZATION AND DISINFECTION 36
9.3 CLEANING,STERILIZATION AND DISINFECTION OF ACCESSORIES 36
9.4 STORAGE 36
9.5 TRANSPORTATION 37
APPENDIX 37
PROMPT INFORMATION EXPLANATIONS 37

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Chapter 1 Overview
1.1 Features
Blood Pressure, SpO2 and Pulse Rate are displayed by big, bright digital LEDs;
Plethysmogram and system parameters are displayed on dot matrix LCD screen;
Accurate NIBP measurement with hardware and software over-pressure protection;
Unique SpO2 measuring technique ensures sensitive and accurate SpO2, Pulse Rate and
Perfusion Index measurement;
SpO2 trend curve display for last 12, 24 or 96 hours;
Up to 400 groups of NIBP measurements can be stored and reviewed by list;
Audible & visible alarm with 3 levels of alarm events;
Nurse call output is available;
NIBP measurement is applicable to adult, pediatric and neonate by patient selection;
Built-in printer is optional to print out waveforms and text information.
1.2 Product Name and Model
Name: “North-vision” Multi-parameter patient monitor
Model: Deluxe-80
1.3 Intended Use
This device is intended for using in hospitals to monitor patient’s blood pressure, SpO2, and
pulse rate.
1.4 Normal Working Environment
a) Ambient temperature range: 10°C ~40°C
b) Relative humidity: ≤80%
c) Atmospheric pressure: 86kPa ~106kPa

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1.5 Symbols on the Monitor

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Chapter 2 Operating Principle
2.1 Conformation
The monitor consists of the main control unit, NIBP measuring module, SpO2 measuring module,
display panel, printer, power supply block etc. and the related accessories for NIBP and SpO2
measurement.
2.2 Overall Structure
The overall structure of the monitor is shown in Fig. 2.1.
Figure 2.1
Deluxe-80 Multi-Parameter Patient Monitor is module designed product; it consists of NIBP
module (optional), SpO2 module (optional), main control unit, printer module, display panel and
power supply block etc.
1. The SpO2 module detects and calculates pulse rate and oxygen saturation (SpO2), and
provides plethysmogram and perfusion index as well.
2. The NIBP module performs the measurement of blood pressure by non-invasive way of
oscillometric technology, including the diastolic, systolic and mean arterial pressure. The
cuffs are designed for adult, pediatric and neonate respectively.
3. The main control unit is in charge of LED and LCD display, keyboard input, data storage,
printing and networking function.

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Chapter 3 Installation and Connection
3.1 Appearance
3.1.1 Front Panel
Figure 3.1 Front panel illustration
Description:
1 Alarm indicator
Alarm indicator
Alarm grades
Alarm events
Red flashing
High priority alarm
Exceeding the limits, low battery voltage
Orange flashing
Medium priority alarm
Probe off
Green
Normal monitoring state
2 SYS: display systolic pressure value
3 DIA: display diastolic pressure value.
4 MAP: Display mean arterial pressure or measuring time of the latest group of
Module Configuration Instructions
According to different needs, user can customize the module configuration by
choosing the necessary modules. This manual shows how to use the monitor of
this model with SpO2and NIBP modules. If only NIBP module is chosen, its
operations are almost the same with the operations mentioned in this manual.

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NIBP measurement; they will be displayed alternately. The format of NIBP
measuring time is “hh:mm”.
Note: two formats to display NIBP value: “×××mmHg” and “××.×kPa”. Refer to section
“4.4.2 NIBP Setup” to set the unit of NIBP value; the conversion relation between “mmHg”
and “kPa”: 1mmHg=0.133kPa.
5 PR: display pulse rate value measured through SpO2 probe or by NIBP
measurement; Unit: “bpm (beats per minute)”.
If SpO2 and NIBP are monitoring at the same time, only the PR value measured
through SpO2 probe is displayed here and the PR measuring by NIBP measurement
is undergoing and recorded in NIBP list.
6 SpO2: Display SpO2 value; Unit: “%SpO2”
7 “ ”: Bar-graph of pulse intensity
8 LCD panel
9 Patient category indicator: “ ” for adult；“ ” for pediatric；“ ” for
neonate; Patient category is selected under sub-menu “Patient Info” within the
setup menu.
10 NIBP: start/cancel NIBP measurement
11 Alarm silence key: Enable/disable alarm silence function. When the
alarm silence indicator on the left of keys is on, it means the system is in alarm
silence status and it laststhis status for 2 minutes. When finishing counting down,
the system will resume normal alarm status automatically, if alarm event occurs
at this time the alarm sound will be effective again.
12 Alarm silence indicator: When it is on, it indicates that the monitor stays in
alarm silence status.
13 Print: print the current measurement data.
14 Up: shift cursor forward/upward
15 ▇OK: to perform confirmation or modification
16 Down: shift cursor backward/downward
17 Display: shift LCD display modes
18 ～: AC Power indicator

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19 : DC Power indicator
AC Power
indicator
DC Power
indicator
Descriptions
Status
ON
(green)
ON
(green)
this device is using mains power supply
OFF
ON
(green)
the battery is being used
OFF
ON
(orange, blinking)
the battery is being used, but battery
voltage is low, the beeper also gives
warning.
ON
(green)
ON
(orange)
this device is using mains power supply
and the battery is being recharged
ON
(green)
OFF
the battery is being recharged while this
device is off.
20 : Power button: Press power button for 3 seconds to start the monitor or
shut off the monitor.
Note: Short time pressing power button for entering the Power Saving Mode screen, then
according to your need to make the device stay in the power saving mode or exit from power
saving mode (this function is optional and needs hardware support).
21 SpO2: SpO2 sensor connector
22 NIBP: NIBP hose connector
3.1.2 Side Panel
The built-in thermal printer is on the left panel. It is easy for user to print waveform and data.
3.1.3 Rear Panel
Figure 3.2 Rear Panel

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Introduction to the rear panel:
1 Handle
2 Fan
3 Nameplate
4 Fuse holder: FUSE T3.15A
5 AC power supply socket
6 Loudspeaker
7 Mounting hole for hanging the monitor
8 Data interface
9 Nurse-call connector
10 : Equal potential terminal
3.2 Installation
3.2.1 Opening the Package and Check
1. Open the package, take out the monitor accessories from the box carefully and place it in a
safe stable and easy to watch position.
2. Open the accompanying document to sort the accessories according to the packing list.
◆Inspect the monitor for any mechanical damages
◆Check all the accessories for any scratch or deformity, especially on connector, wire
and probe parts
If in doubt, please contact the local dealer or our company in case of any problems. We are to
offer you the best solution for your satisfaction.
3.2.2 Connecting the Power Supply
1. When powered by AC mains power supply:
◆Make sure that the AC mains power supply is within 100-250VAC with 50Hz or 60Hz.
◆Use the power cord provided by the manufacturer. Insert one end of it to the power
port of the monitor and the other end to the single-phase mains power outlet with
protected earth.
◆Caution: if necessary, make the monitor grounded properly by the provided grounding
wire.
2. When powered by built-in battery
◆Install battery: refer to 3.3.4 Battery Installation.
◆Caution: it’s better to recharge the battery after it is used up, the charging time should
be 13~15 hours long.

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3.2.3 Starting the Monitor
The system performs self-test and enters initial display after switching on the monitor, and the orange
alarm indicator blinks to inform that the user can begin operating it.
◆Check all the applicable functions to make sure that the monitor works normally.
◆If the battery is applied please recharge it after using the monitor to ensure sufficient
power storage.
Do not use the device to monitor the patient if there are indications of damage or reminders of
error.
3.3 Sensor Placement and Connection
3.3.1 Blood Pressure Cuff Connection
1. Select a cuff of appropriate size according to the age of the subject. Its width should be 2/3 of
the length of the upper arm. The cuff inflation part should be long enough to permit wrapping
50-80% of the limb concerned. See the table below for the dimensions:
Cuff Type
Arm circumference
Cuff width
Neonate Cuff
6.0cm～9.5cm
3cm
Small-sizedCuff for Pediatric
6cm～11cm
4.5cm
Middle-sized Cuff for Pediatric
10cm～19cm
8cm
Large-sized Cuff for Pediatric
18cm～26cm
10.6cm
Adult Cuff
25cm～35cm
14cm
Table 3-1
Figure 3.3 Cuff Placement
2. Connect the cable to connector marked with the NIBP icon.
Safety Instructions for NIBP Monitoring
When taking the measurement of a pediatric or neonate’s (less than 10 years old) blood
pressure, do NOT operate in the adult mode. The high inflation pressure may cause
lesion or even body putrescence.
It is recommended to take the blood pressure measurement manually. Automatic
measurement should be used at the presence of a doctor/nurse.

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NIBP monitoring is prohibited to those who have severe hemorrhagic tendency or with
sickle cell disease, or partial bleeding will appear.
Pay attention to the color and sensitivity of the limb when measuring NIBP; make sure
the blood circulation is not blocked. If blocked, the limb will discolor, please stop
measuring or remove the cuff to other positions. Doctor should examine this timely.
Confirm your patient category (adult, pediatric or neonate) before measurement.
Do NOT bind NIBP cuff on limbs with transfusion tube or intubations or skin lesion
area, otherwise, damages may be caused to the limbs.
Prior to use of the cuff, empty the cuff until there is no residual air inside it to ensure
accurate measurement.
Do NOT twist the cuff tube or put heavy things on it.
When unplugging the cuff, hold the head of the connector and pull it out.
3.3.2 SpO2Sensor Connection
SpO2sensor is a very delicate part. Please follow the steps and procedures in operating it. Failure to
operate it correctly can cause damage to the SpO2sensor.
Operation procedure:
1. Connect the SpO2 sensor to the connector labeled “SpO2”. When unplugging the
probe, be sure to hold the head of the connector and pull it out.
2. If the finger clip SpO2 sensor is used, insert one finger into the sensor (index finger,
middle finger or ring finger with short nail length) as shown in the figure below.
Figure 3.4 Finger clip SpO2 sensor placement
3. If the neonate SpO2 sensor is used, please follow Figure 3.5 to connect.

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Figure 3. 5 Neonate SpO2 sensor placement
Safety Introductions for SpO2 Monitoring
Continuous use of finger clip SpO2 sensor may result in discomfort or pain, especially
for those patients with microcirculatory problem. It is recommended that the sensor
should NOT be applied to the same finger for over two hours.
SpO2 measuring position must be examined more carefully for some special patient.
Do NOT place the SpO2 sensor on the finger with edema or fragile tissue.
Please do not allow the cable to be twisted or bended.
Do NOT put the SpO2 sensor and pressure cuff on the same limb, otherwise the NIBP
measuring will affect SpO2 measuring and cause the alarm error.
Using nail polisher or other cosmetic product on the nail may affect the accuracy of
measurement.
The fingernail should be of normal length.
Do NOT use the damaged SpO2 sensor.
The SpO2 sensor can not be immerged into water, liquor or cleanser completely,
because the sensor has no capability of waterproofness.
3.3.3 Loading printing paper
Operation procedures for loading printing paper:
1. Press both “OPEN” notches with force on printer shield with two thumbs to open it.
2. Move the tab of rubber roller lock at the left 90°upwards to unlock it, refer to the
following figure with mark ①.
3. Cut one end of the paper into triangle, and loadthepaper from the underside of the rubber
roller.
4. Turn the roller clockwise to get the paper rolled, and put the paper roll into the

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compartment.
5. Pull the paper out of paper slot on the shield.
6. Move the tab of the rubber roller lock 90°downwards to lock it.
7. Put the shield back in position and secure it.
Operation procedures for taking out printing paper roll:
1~2 steps are the same with the 1~2 steps mentioned above for loading printing paper.
3. Roll the loading roller anti-clockwise and pull the paper out.
4~5 steps are the same with the 6~7 steps mentioned above for loading printing paper.
Figure 3.6 Loading and taking out printing paper
3.3.4 Battery Installation
1. Ensure that the monitor is not connected to AC power supply and the monitor is turned
off.
2. Open the battery cover and place the battery in the direction as shown in Fig. 3.7 to insert
the battery into any one of battery compartments. Do not insert battery with their
polarities reversed.
3. Move the battery baffle to secure battery.
4. Close the battery cover.
Note: you can install optional one more battery to prolong the working time.

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Figure 3.7 Battery Installation
Note:
●Do not insert battery terminal with its polarities reversed, or the monitor can not
be started.
●Please take out the battery before transport or storage.

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Chapter 4 Operations
4.1 Initial Monitoring Screen
When the module configuration is “SpO2+NIBP”, once powered up, the LCD will display the
initial monitoring screen with SpO2 plethysmogram, this is the default display screen.
Figure 4.1 Default Display Screen
The LCD screen will display the information by different display views, short pressing “ ” key
to shift screen display among 3 display views: SpO2 plethysmogram screen (default screen), SpO2
trend graph screen, and NIBP list screen. Long pressing “ ” key will enter the setup menu screen.
For every display view, the display area is divided into 3 parts: title area, main display area, and
prompt info area (see Figure 4.1). The prompt info area contains 3 segment of information: status or
event indication at the left, patient ID number in the middle, real time clock at the right (also see
Figure 4.1)
4.1.1 Screen Description
Title area:
“PI: 3‰”: the perfusion index is 3‰; it displays only when “Setup Menu→SpO2→PI
Display” is set as “ON”.
“PLETH”: Mark of SpO2 plethysmogram，when “PLETH” displays in title area, the
main display area will be SpO2 plethysmogram, and this display screen is the default
screen.
Main display area:
When SpO2 sensor is placed on the patient and connected to the monitor well, a trace of sweeping
waveform (plethysmogram) will be displayed in the main display area (as shown in Figure 4.1).
If the SpO2 sensor is disconnected from the monitor or off from the patient, the plethysmogram will
become a base line in main display area and “Probe off” will appear at the left side of prompt info
area (as shown in Figure 4.2).

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Figure 4.2 Probe Off
Prompt Info:
Status or event indication segment:
This segment will display the probe status, alarm silence counting-down timer, over
limit warning and other error messages for technical warning. If more than one event
occurs or more status appears, the indication message will be displayed alternately at
this segment.
“NIBP C-D: 120”: the counting-down timer of NIBP measurement is 120 seconds. This
prompt message appears only when the NIBP measuring mode is set as “AUTO X”.
“mute C-D: 120”: the counting-down timer of alarm silence is 120 seconds. This
prompt message appears only when the alarm silence is enabled.
Patient ID segment:
“01”: Patient ID number.
Real time clock segment:
“17:44:59”: the current time.
4.1.2 Operation Instructions
“ ” key: press this key to shift to next display view (SpO2 trend graph).
“ ” key: Press it to print a trace of SpO2 plethysmogram, press it again to stop printing.
“ ” key: start/cancel NIBP measurement.
“ ” key: Alarm silence switch, press it to enable/disable alarm silence.

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4.2 SpO2 Trend Graph Display
Short pressing “ Display” key to shift the screen view to trend graph display screen, as shown in
Figure 4.3.
Figure 4.3 Trend Graph
“12 hours”: the trend length of trend graph; three options: “12”, “24” or “96” hours;
when the selection is 12 hours, the upper trend graph will display SpO2 trend curve
for last 12 hours.
“cursor on”: enable the display of cursor on trend graph, i.e. the vertical cursor line
displayed in trend graph, so the user can move the cursor to inspect the SpO2 value at
the given time.
Operation Instructions
1. Press “▲” key or “▼” key to highlight “trend length” or “cursor on” selection.
2. Press “■” key to confirm.
3. Press “▲” key or “▼” key again to select value of trend length (12/24/96 hours) if the
selecting box stays in “trend length” option, or to move the cursor if the selecting box stays in “cursor
on” option.
Instructions for viewing the trend curve:
● Select “cursor on” and press “■” key to confirm, and “cursor on” becomes “cursor off” ,
then you can press “▲” key or “▼” key to move the vertical cursor, the list box below
will display SpO2 value and the time value at the point where the cursor stays. Move
cursor back and forth this way, you can view the SpO2 trend (12/24/96 hours long). Press
“■” key again to exit trend viewing.
●When pressing “▲” key or “▼” key to move cursor, the moving step is variable. The
rule is that the initial step is 1 point, after pressing “▲” or “▼” key towards the same
direction for 5 times, the step becomes 5 points, and with 5 more pressing the step
becomes 10, then 20. No matter what step is, as long as you press “▲” or “▼” key towards
the other direction, the step becomes 1 and towards the other direction.
4. press：
“ ” key: press this key to shift to next display view.