North-Vision Tech Handheld-100 User manual

User Manual for Handheld Pulse Oximeter
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North-vision Handheld Pulse Oximeter
Handheld-100
User Manual
Version: 2. 2
Issued by: Sara Lo Date: 5/11/2020
Reviewed by: Albert Huang Date: 5/11/2020
Document No: UM-HO1-201212-01
North-Vision Tech. Inc.
2460

User Manual for Handheld Pulse Oximeter
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Instructions to User
Dear Customer,
Thank you for purchasing this quality product. Please read the
manual very carefully before using this device. Failure to follow
these instructions can cause measuring abnormality or damage to
the Oximeter.
No part of this manual may be photocopied, reproduced or
translated into another language without the prior written consent.
We reserve the right to revise and amend it at any time without
prior notice.
Notes:
• The contents contained in this manual are subject to change
without prior notice.
• Information furnished by our company is believed to be
accurate and reliable. However, no responsibility is assumed
by us for its use, or any infringements of patents or other rights
of third parties that may result from its use.

User Manual for Handheld Pulse Oximeter
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Instructions for Safe Operation
Check the device to make sure that there is no visible
damage that may affect user’s safety and measurement
performance. It is recommended that the device should be
inspected minimally before each use. If there is obvious
damage, stop using the device.
Necessary service must be performed only by qualified
technicians. Users are not permitted to service this device.
The oximeter must not be used with the devices and
accessories not specified in User Manual.
Cautions
Explosive hazard—DO NOT use the oximeter in
environment with inflammable gas such as some ignitable
anesthetic agents.
DO NOT use the oximeter while the Patient is under MRI
or CT scanning. This device is NOT MRI Compatible.
Warnings
Discomfortable or pain may occur if using the sensor of this
device continuously on the same location for a long time,
especially for the patients with poor microcirculation. It is
recommended that the Oximeter should not be applied to the
same location for longer than 2 hours or less if any abnormal
condition is found. Frequently check and re-position the
Oximeter sensor.

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For the individual patients, there should be a more prudent
inspecting in the placing process. The sensor cannot be
placed on the edema and tender tissue.
The local law should be followed when disposing of the
expired device or its accessories.
Attentions
Keep the oximeter away from dust, vibration, corrosive
substances, explosive materials, high temperature and
moisture.
If the Oximeter gets wet, please stop operating it and do not
resume operation until it is dry and checked for correct
operation. When it is carried from a cold environment to a
warm and humid environment, please do not use it
immediately. Allow at least 15 minutes for the Oximeter to
reach ambient temperature.
DO NOT operate the button on the front panel with sharp
materials or sharp point.
DO NOT use high temperature or high pressure steam
disinfection on the oximeter and probes. Refer to related
chapter for instructions regarding cleaning and disinfection.
The intended use of this device is not for therapy purpose.
Declaration of Conformity
The manufacturer hereby declares that this device complies
with the following standards:
IEC 60601-1, ISO 80601-2-61:2011

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and follows the provisions of the council directive
MDD93/42/EEC.
Caution: U.S. federal law restricts this device to sale
or use by or on the order of a physician.

VI
User Manual for Handheld Pulse Oximeter
Table of Contents
1Overview.................................................................................1
1.1 Appearance.......................................................................1
1.2 Product Name and Model.................................................2
1.3 Structure...........................................................................3
1.4 Features............................................................................3
1.5 Intended Use..................................................................... 3
1.6 Working Environment......................................................3
2Installation of Battery and Holder........................................4
3SpO2 Probe Connection. ........................................................6
4Operation................................................................................8
4.1 Power on/off the Oximeter............................................... 8
4.2 Default Display Screen.....................................................8
4.3 Display Screen with PI Value......................................... 10
4.4 Menu Setup. ...................................................................10
4.5 Data Recall..................................................................... 16
5Technical Specifications. ..................................................... 19
6Over-limit Indication...........................................................22
6.1 Limit settings..................................................................22
6.2 Alert sound mute setting................................................. 22
7Packing List.......................................................................... 23
8Repair and Maintenance. ....................................................24
8.1 Maintenance...................................................................24
8.2 Cleaning and Disinfecting Instruction............................24
9Troubleshooting................................................................... 25
Appendix..................................................................................26

User Manual for Handheld Pulse Oximeter
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1Overview
1.1Appearance
Data interface
Display screen
Navigation keys
Mode/OK
Reserved port
Power/Back
Recall/Mute
SpO2 probe
connector
Figure 1-1
1. Display screen: display SpO2 plethysmogram and parameter
values.
2. Navigation key:
 : Up/Left/Increase

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Press this key, the default screen can be shifted to display pulse
rate (PR) or perfusion index (PI). If on the system setup screen,
press it to move the cursor upwards or to the left and adjust
parameter values.
: Down/Right/Decrease
Its function is similar with the key “¤ : Up/Left/Increase”.
3. (Mode/OK): press this key, the screen can be shifted
between default screen display and alternative screen display;
longtime press it, the menu screen will be displayed; when you
finish parameter setting, press this key to confirm.
4. (Data interface): used for uploading data (Optional
function).
5. (Reserved port): reserved for futureused..
6. (Power/Back): Power on/off the device by longtime
pressing; short time press it to back to the previous level of menu
while setting menu operation.
7. (Recall/Mute): Longtime press it to enter SpO2 trend data
recall screen; when the device is beeping, short time pressing will
mute the indication sound, the mute state will persist for about 90s.
After this mute period (90s), then the indication sound will resume.
8. Icon: “SpO2”: SpO2 Probe Connector.
1.2 Product Name and Model
Name: Handheld Pulse Oximeter
Model: Handheld-100

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1.3 Structure
It consists of the main unit and SpO2 probe.
1.4 Features
 It is lightweight, small in size and easy to carry
 Color LCD to display plethysmogram and parameters
 Monitor SpO2 and Pulse Rate simultaneously
 PI (Perfusion Index) display is available
 Up to 384 hours storage and recall of SpO2 and PR data.
 Audible and visual alert function is available
 Data transmission to PC for view and analysis (Optional)
 Power saving mode is available
1.5 Intended Use
Handheld Oximeter is intended for measuring the pulse rate and
functional oxygen saturation(SpO2) through a testee’s finger. It
is applicable for spot-check of SpO2 and pulse rates in hospitals
and clinics. The device is used for all groups including
infant/neonate, pediatric/child and adult, but they need to select
appropriate type of sensor to fit different age of user.
1.6Working Environment
Operating temperature: 5~40℃
Operating humidity: 15~93%
Atmospheric pressure: 70kPa~106kPa

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2Installation of Battery andHolder
1）Open the rear panel with coin or an ordinary flat screwdriver,
as shown in Figure 2-1.
Figure 2-1
2）AA Alkaline batteries:
① If AA alkaline batteries (non-chargeable) are provided, then
according to the polarity mark, insert three AA batteries into
battery house, as shown in Figure 2-2.
Figure 2-2 Figure 2-3 Fixing Holder

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3）Close the battery cover and lock it.
4）Fixing Holder, as shown in figure 2-3.
Notes: ① When the device is provided with AA alkaline batteries
and it shows low battery, the user should replace the batteries in
time.
Safety instruction for operation:
 Donotthrowthebatteryintothewater,liquidandfire.
 Keep the battery out of the reach of the child.
 Do not disassemble the battery.
 The local law should be followed when disposing of the
expired device or its accessories in order to protect
environment from being polluted.
Please remove the battery and put it to specified condition if
the device will not be used for a long time.

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If the battery is damaged, please replace it with the same
model AA alkaline battery provided by the same
manufacturer.
3SpO2 Probe Connection
Connect the SpO2 probe to the connector labeled “SpO2” at the
right side of the Oximeter. After starting up the Oximeter, insert
one finger (index finger, middle finger or ring finger with proper
nail length) into the probe according to the demonstration shown
in the following figure.
Figure 3-1 Illustration of using SpO2 probe (finger clip type)
Instructions of Operation
1. The finger should be put in properly andcorrectly.
2. Do not shake the finger and keep at ease during
measurement.
3. Do not put wet finger directly into sensor.

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4. Avoid placing the sensor on the same limb which is wrapped
with a cuff for blood pressure measurement or during venous
infusion.
5. Do not let anything block the emitting light from thesensor.
6. Vigorous exercise and electrosurgical device interference
may affect the measuringaccuracy.
7. Using enamel or other makeup on the nail may affect the
measuringaccuracy.
8. If the first reading appears with poor waveform (irregular or
not smooth), then the reading is unlikely true, the more stable
value is expected by waiting for a while, or a re-inserting
finger is needed whennecessary.

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4Operation
4.1 Power on/off the Oximeter
➢ Long " power/back key for 1~2 seconds, then
the oximeter will be powered on or off.
➢ During measurement, if the "Probe off" status is
sustaining for longer than one minute, and if there is no
any key operation for one minute, then the device will
power off automatically.
4.2 Default Display Screen
Press ”power key for 2 seconds to start up the Oximeter, the
display screen shows the prompt "Please use appropriate sensor
according to the patient type and change the related settings"
firstly, then the screen will display the default screen, as shown in
Figure 4-1.
Figure 4-1 Default Screen
Description:
Sound indicator " means the device is on mute status, the

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user can turn on the indication sound by short pressing
recall/mute " " key. During the measurement, over-limit
event or probe off event can activate the alert indication sound.
“ ”: Memory full icon; if the memory is full, the memory
full icon " appears on the screen. No display of this icon
means the current storing space is not full. If the memory is
full, the data storing will continue in such way the new record
will overwrite the oldest record, so that it's recommended to
upload the stored data into the computer in time.
During the measurement, short time press recall/mute " "
key to turn off (or resume) the device sound (including pulse
beep sound, audible alert and key click), the pulse beep sound,
while the pulse symbol " " still blinks. Refer to Section
6.2 for detail of the sound mute function.
Note: The pitch tone of pulse beep (dididi...) is modulated by
the SpO2 value, that means the pitch tone changes when the
measured SpO2 changes. The higher the SpO2 value is, the
higher the tone frequency of pulse beep (sound becomes
sharper); The lower the SpO2 value is, the lower the tone
frequency of pulse beep (sound becomes flatter).

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4.3 Display Screen with PIValue
On the default display screen, press “/” Navigation key to shift
screens between default screen and display screen with PI value.
The display screen with PI value is shown below.
Figure 4-2 Display Screen with PI Value
4.4 Menu Setup
On the above mentioned screens, longtime press “ ” key for
entering into setup menu screen (as shown in Figure 4-3).
Screen Description
➢ “Setting”: set parameter values, refer to Chapter 4.4.1 for

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details.
➢ “Upload data”: enter into data uploading state, refer to
Chapter 4.4.2 for details.
➢ "Default": enter into the factory default setting, refer to
Chapter 4.4.3 for details.
➢ “Version”: for viewing version number of the software,
refer to Chapter 4.4.5 for details.
4.4.1 Setting
On the menu screen, select “Setting” and then press “ ” key
for entering into system setup screen. The setup screen is as shown
in the followingfigures.
Figure 4-4 System Setup Screen

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Operation Instructions:
➢ Patient: according to the type of SpO2 probe, the matched
patient type should be selected, there are two options:"ADU
" for adult, and " NEO " forpediatric.
➢ SpO2 Lo-Limit: SpO2 low limit setting; range: 50%~99%,
the step is 1%. The factory default value for adult is 90%
and 95% for pediatric.
➢
PR Hi-Limit: High limit setting of pulse rate; range:
100~240bpm. From 100 to 150, the step is 1bpm, and from
150 to 240, the step is 5bpm. The factory default value for
adult is 120bpm and 160bpm for pediatric.
➢
PR Lo-Limit: Low limit setting of pulse rate; range:
30~99bpm, and the step is 1bpm. The factory default value
for adult is 50bpm and 60bpm for pediatric.
Note: When the SpO2 reading is lower than the preset alert setting
or the PR reading is higher or equal to the preset alert setting,
then the over-limit alert event will be activated, that's, the alert
sound "bibibibi" occurs, and the corresponding reading(s) blinks.
When measured on pediatric, if the SpO2 reading is lower or
equal to the preset alert setting for 10 seconds, then the alert
sound and blinking display will be activated.
➢
Date: Date setting
1 ） When cursor stays on the Year of the date, press “ ”
(Mode/OK) key to active Yearoption, the cursor flashes on

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the Year of the date;
2 ） Press / (Navigation key) to adjust year.
3 ） Press ” (Power/back) key or ” (Mode/OK) key to
confirm and exit from date setting.
4 ） The procedures of adjusting Month value and Day value
are the same with Yearadjustment.
Date Format: yyyy-mm-dd
➢ Time: Timesetting
➢ Recording: Time interval for recording data (SpO2 & PR),
there are five options: “1s, 2s, 4s, 8s” and “OFF”.
1) "1s": the least length of data record is set to 30 seconds, and
the maximal length for one record is limited to 1 hour. The
total storage time is up to 48 hours.
2) "2s": the least length of data record is set to 60 seconds, and
the maximal length for one record is limited to 2 hours. The
total storage time is up to 96 hours.
3) "4s": the least length of data record is set to 120 seconds, and
the maximal length for one record is limited to 4 hours. The
total storage time is up to 192 hours.
4) "8s": the least length of data record is set to 240 seconds, and
the maximal length for one record is limited to 8 hours. The
total storage time is up to 384 hours.
Note: The setting operations of other parameters (such as TIME,
PATIENT,RECORDING INTERVAL, POWER SAVING etc.)
are the same with date setting.

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5) When the option is set to “OFF”, the device will not store the
measuring data.
➢
Power saving: power saving setting; two options: "on" and
"off". The factory default setting is "on". If the power
saving mode is on during measurement, and there is no key
operation for 2 minutes, the screen display will be dim for
power saving. The display brightness will resume to
normal condition by pressing any key.
4.4.2 Upload Data
On the menu screen, select “UPLOAD DATA” and then press
“ ” key for entering into connecting status (as shown in Figure
4-5).
Note: Make sure the provided USB data cable is well connected
between the device and PC before uploading data.
When you transmit data (SpO2 and PR values) to your computer,
please let the oximeter stay in connecting status. then data
uploading will be activated. Refer to the instruction in “Oximeter
Data Manager User Manual” for detailed operation.