dynarex Resp-O2 User manual

Manufactured for:
Dynarex Corporation
10 Glenshaw Street
Orangeburg, NY 10962
USA • www.dynarex.com
Made in China
-4°F
-20°C
+122°F
+50°C
10%
95% CAUTION: Federal (USA) Law
restricts this device to sale by or
on the order of a physician
Handheld
Pulse
Oximeter
User Manual
Reorder No. 36403

2 Handheld Pulse Oximeter (Reorder No. 36403)

Handheld Pulse Oximeter (Reorder No. 36403) 3
All information contained in this publication is believed to be
correct. We shall not be liable for errors contained herein nor
for incidental or consequential damages in connection with the
furnishing, performance, or use of this material. The information
this publication refers to is protected by copyrights or patents
and does not convey any license under the patent rights of our
company, nor the rights of others. We do not assume any liability
arising out of any infringements or patents or other rights of third
parties.
Copyright © 2021. All rights reserved.
Contents of this material are subject to change without prior notice.
R220429

4 Handheld Pulse Oximeter (Reorder No. 36403)
TABLE OF CONTENTS
1. Introduction .............................................................................6
1.1 Brief Introduction.............................................................. 6
1.2 Safety Information............................................................ 6
1.3 Equipment Symbols....................................................... 11
1.4 Equipment Classication................................................ 12
1.5 Package Contents.......................................................... 12
2. General Descriptions............................................................. 13
2.1 Front Panel .................................................................... 13
2.2 Rear Panel..................................................................... 15
2.3 Product Features ........................................................... 17
2.4 Intended Use.................................................................. 17
3. Getting Started...................................................................... 18
3.1 Unpacking and Checking............................................... 18
3.2 Environmental Requirements......................................... 18
3.3 Connect the Sensor .......................................................19
3.4 Starting or Shutting Off the Oximeter.............................20
4. Setting ID, Date and Time .....................................................20
4.1 Date & Time Setting .......................................................21
4.2 ID Number Setting .........................................................22
5. Take a Measurement.............................................................22
5.1 Factors That May Affect The Measurement...................23

Handheld Pulse Oximeter (Reorder No. 36403) 5
TABLE OF CONTENTS (Continued)
6. History Data Reviewing.........................................................26
6.1 Character Denition .......................................................26
6.2 Reviewing Operation......................................................26
7. Alarm Setting.........................................................................27
7.1 Alarm Priority .................................................................27
7.2 Character Denition .......................................................28
7.3 SpO2Alarm Setting ........................................................28
7.4 PR Alarm Setting............................................................29
7.5 Alarm on/off....................................................................29
7.6 Alarm Activation .............................................................30
8. Beep on/off............................................................................ 31
9. Maintain and Cleaning ..........................................................32
9.1 Safety Checks................................................................32
9.2 Calibration and Verication ............................................35
9.3 Trouble Shooting............................................................36
9.4 Warranty ........................................................................37
APPENDIX A Specications .......................................................39
APPENDIX B..............................................................................42

6 Handheld Pulse Oximeter (Reorder No. 36403)
1. INTRODUCTION
1.1 Brief Introduction
Thank you for purchasing the Handheld Pulse Oximeter.
The device is designed to measure SpO2and PR, delivering
visual and audio alarm, sensor off alarm, data storage and
review etc. Please read this manual carefully before using it.
1.2 Safety Information
Conception of Warning, Precaution and Notice
The Warning, Precaution and Notice in this document mean:
WARNING: Indicates a potential hazard or unsafe practice
that, if not avoided, will result in death or serious injury.
CAUTION: Indicates a potential hazard or unsafe practice
that, if not avoided, could result in minor personal injury or
product/ property damage.
NOTICE: Provides application tips or other useful
information to ensure that you get the most from your
product.
WARNINGS
• Before putting the system into operation, verify that the
equipment, connecting cables and accessories are in
correct working order and operating condition.
• To avoid explosion hazard, do not use the oximeter in the
presence of ammable anesthetics, vapors or liquids.
• Do not open the equipment housings; electric shock
hazard may exist. All servicing and future upgrades must
be carried out by trained personnel and authorized by our
company only.

Handheld Pulse Oximeter (Reorder No. 36403) 7
1. INTRODUCTION (Continued)
• The Pulse Oximeter is specied for use by medical
professionals only.
• Prolonged use of the probe/sensor or the patient’s
condition may require changing the sensor site
periodically. Change the sensor site and check skin
integrity, circulatory status, and correct alignment at least
every 4 hours. Prolonged use may cause blisters, skin
deterioration, and discomfort.
• When connecting this oximeter to any instrument,
verify proper operation before clinical use. Refer to
the instrument’s user manual for full instructions. The
equipment connected to the Pulse Oximeter’s data
interface must be certied according to the respective IEC
standards, i.e., IEC950 for data processing equipment
or IEC 601-1 for medical electrical equipment. All
combinations of equipment must be in compliance with
IEC601-1-1 systems requirements.
• Sensor malfunction may cause inaccurate data, possibly
resulting in patient injury or death, so pay close attention to
the sensor and inspect it often.
• The physiological data and alarm messages displayed
on the equipment are for reference only and cannot be
directly used for diagnostic interpretation.
• Do not rely exclusively on the audible alarm system for
patient monitoring. Adjustment of alarm volume to off may
result in a hazard to the patient. Remember that alarm
settings should be customized according to different
patient situations and always keeping the patient under
close surveillance is the most reliable way for safe patient
monitoring.

8 Handheld Pulse Oximeter (Reorder No. 36403)
1. INTRODUCTION (Continued)
• Worn out data cables may cause inaccurate data. If the
data is being used as a reference to treat a patient, pay
attention to the data cable and check it frequently.
• When using the equipment with electrosurgical units
(ESU), make sure the patient is safe.
• Do not come into contact with the patient during
debrillation. Otherwise serious injury or death could
result.
• Single-use accessories should never be reused. Route all
cables safely to avoid a stumbling hazard and accidental
cable disconnection. Wrap and secure excess cabling to
avoid risk of entanglement or strangulation of patients or
personnel.
CAUTIONS
• Autoclaving, ethylene oxide sterilizing, or immersing the
sensors in liquid may cause inaccurate readings.
• To ensure patient safety, only use the parts specied in this
manual.
• The operator must be thoroughly familiar with the
information in this manual before using the device.
• Magnetic and electrical elds are capable of interfering
with the proper performance of the equipment. For this
reason make sure that all external devices operated in the
vicinity of the equipment comply with the relevant EMC
requirements. Mobile phones, X-ray equipment or MRI
devices are a possible source of interference as they may
emit higher levels of electromagnetic radiation.

Handheld Pulse Oximeter (Reorder No. 36403) 9
1. INTRODUCTION (Continued)
• Unplug the sensor from the oximeter before cleaning or
disinfecting it. If liquid is accidentally spilled on the unit,
clean and dry thoroughly before reuse.
• Do not try to use the SpO2and NIBP measurement on the
same arm at the same time. This could potentially affect
measurement accuracy.
• At the end of its service life, the equipment must be
disposed of in compliance with the guidelines regulating
the disposal of such products. If you have any questions
concerning disposal of the equipment, please contact your
distributor.
• Always install and carry the equipment properly to avoid
damage caused by drop, impact, strong vibration or other
mechanical force.
NOTES
• Put the equipment in a location where you can easily see
the screen and access the operating controls.
• Keep this manual in the vicinity of the equipment so that it
can be easily obtained when needed.
• The software was developed with compliance to
IEC60601-1-4 to minimize the possibility of software
errors.
• SpO2 measurements may be inuenced by high ambient
light, especially sunlight. Shield the sensor area if
necessary.
• Dyes introduced into the bloodstream, such as methylene
blue, indocyanine green, indigo carmine, and uorescein,
may inuence the accuracy of the SpO2reading.

10 Handheld Pulse Oximeter (Reorder No. 36403)
1. INTRODUCTION (Continued)
• Any condition that restricts blood ow, such as use of
a blood pressure cuff or extremes in systemic vascular
resistance, may cause a failure to determine accurate
pulse rate and SpO2readings.
• Remove ngernail polish or articial ngernails before
applying SpO2 sensors. Fingernail polish or articial
ngernails may cause inaccurate SpO2readings.
• Optical cross-talk can occur when two or more sensors are
located in adjoining areas. It can be eliminated by covering
each site with opaque material. Optical cross-talk may
adversely affect the accuracy of the SpO2readings.
• Obstructions or dirt on the sensor’s red light or detector
may cause a sensor failure. Make sure there are no
obstructions and the sensor is clean.
• For routine equipment maintenance, please refer to the
service procedures at the associated section as indicated
in the manual.
• As to the other concerns for attention, please carefully look
through the specic chapter in enclosed instructions.
• This manual describes all features and options. This model
may not have all accessories mentioned in this manual.
• Federal Law restricts this device to sale by or on the order
of a physician.

Handheld Pulse Oximeter (Reorder No. 36403) 11
SECTION HEADER1. INTRODUCTION (Continued)
1.3 Equipment Symbols
SYMBOL SYMBOL NOTES
Type BF applied part.
Attention! Refer to the relevant information.
Read operator’s manual carefully before using
the oximeter.
Non-ionizing radiation
Manufacture date
Manufacturer
Serial number
Temperature Limitation
Humidity Limitation
IPX1 Degree of protection against liquid entry
Fragile: Shows handle with care during
transportation
Shows not to get the package wet
Not made with natural rubber latex
CAUTION: Federal (USA) law prohibits this device
to sale by or on the order of a physician.

12 Handheld Pulse Oximeter (Reorder No. 36403)
SECTION HEADER1. INTRODUCTION (Continued)
1.5 Package Contents
• Pulse Oximeter manual
• Sensor manual
• Finger Sensor with cable
• USB cable
• Software disk
1.4 EquipmentClassication
ClassicationaccordingtoIEC-60601
According to the type of
protection against electrical
shock
Internal electrical power
source equipment
According to the degree of
protection against electrical
shock
Type B equipment
According to the degree of
protection against harmful
ingress of water
Ordinary equipment
(enclosed equipment without
protection against ingress of
water)
According to the methods of
sterilization or disinfection
Non-sterilizable:
Use of liquid surface
disinfectants only.
According to the mode of
operation Continuous operation
Equipment not suitable for use in the presence of a ammable
anesthetic mixture, air or with oxygen or nitrous oxide.

Handheld Pulse Oximeter (Reorder No. 36403) 13
SECTION HEADER2. GENERAL DESCRIPTIONS
The Handheld Pulse Oximeter has 8-segment digital LED for
displaying data. It can display the SpO2and pulse rate value, time
& date, ID number, pulse bar as well as battery status etc.
2.1 Front Panel
Please refer to Fig. 1. The display in Fig. 1 is a normal
screen.
1
2
3
4
5
6
7
8
9
10
11
Fig. 1 Front panel
Instruction of Fig. 1
1. SpO2: SpO2value
2. PR: Pulse rate

14 Handheld Pulse Oximeter (Reorder No. 36403)
SECTION HEADER2. GENERAL DESCRIPTIONS (Continued)
3.
Low power indicator. When the power is lower than
2.4V, the lamp indicated will be lighted, and the oximeter
will power off automatically when the power is lower than
2.3V.
4. Alarm Indicator: When technical alarm or physiological
alarm occurs, the lamp indicated will turn red.
5. Power button
6. Navigation buttons: you can select and set the different
parameters. These three buttons below are also used as
shortcut buttons:
a) Press the up button, the unit will display the ID number.
b) Press the right or left button, the unit will display the
Error Code.
7. Menu button: You can return to the measurement screen
or switch the main menu item by this button.
8. Reserved function.
9. Beep off/on Indicator: When beep is off, the lamp
indicated by it is on.
10. Alarm light: When there is an alarm, the associated lamp
will be lighted.
11. Pulse bar: The pulse bar is in proportion to the pulse
volume.
NOTE: This manual describes all features and options.
However equipment may not have all accessories.

Handheld Pulse Oximeter (Reorder No. 36403) 15
SECTION HEADER2. GENERAL DESCRIPTIONS (Continued)
2.2 Rear Panel
1
23
4
Fig. 2 Rear panel
Rear panel introduction
1. Battery compartment – Uses 2 AA-size alkaline batteries
(not included)
2. Fixing hole
3. Fixing screw
4. Battery cover
Battery Installation (Batteries Not Included):
1. Open the battery cover: Rotate the xing screw slightly
in the rear panel to the up position which is marked with
“” and then open the cover.

16 Handheld Pulse Oximeter (Reorder No. 36403)
SECTION HEADER2. GENERAL DESCRIPTIONS (Continued)
2. Install 2 batteries as indicated by the polarity sign.
NOTE: Be sure to insert the batteries in the correct
polarity, as indicated by polarity markings (+ and -)
inside the battery cover.
3. Close battery cover: Close the battery cover and rotate
the screw to the position, and the batteries are locked.
Make sure that the polarity of the batteries is correct,
otherwise the unit cannot operate normally.
Battery Life and Replacement
When the low-power indication lamp is lighted, please
replace the batteries with new ones as needed.
• Always turn the unit off before replacing the batteries.
• Dispose of the used batteries according to the applicable
local regulations.
WARNINGS!
If battery contents should get into your eyes, immediately rinse
with plenty of clean water. Consult a doctor immediately.
CAUTIONS!
• Do not use batteries not specied for this unit.
• Do not insert the batteries with the polarities in the wrong
direction.
• Do not dispose of batteries in re.
• If battery contents should get on your skin or clothing,
immediately rinse with plenty of clean water.

Handheld Pulse Oximeter (Reorder No. 36403) 17
SECTION HEADER2. GENERAL DESCRIPTIONS (Continued)
• Remove the batteries from this unit when you are not
going to use it for a long period of time (approximately
three months or more).
• Do not use batteries of different types together.
• Do not use new and used batteries together.
2.3 Product Features
• Rubber grip design offers special protection.
• Compact, light-weight design for simple, one-hand
operation.
• High brightness LED displays SpO2, pulse rate and pulse
bar.
• Holds up to 99 patients’ ID info and 72-hour record storage.
• Visual alarm, audio alarm, low battery alarm.
• Data transfer to PC for storage or printing.
• Convenient 2 AA-size alkaline batteries (not included).
2.4 Intended Use
The Handheld Pulse Oximeter is intended for use in non-
invasively measuring and displaying functional oxygen
saturation of arterial haemoglobin (SpO2), and pulse rate of
adult and paediatric patients in hospitals and home care. Not
for continuously monitoring. The device is not intended for
use under conditions such as motion and low perfusion. The
device is not intended for single use. The device is a stand-
alone device and the application sites are the nger and the
hand of a patient.

18 Handheld Pulse Oximeter (Reorder No. 36403)
SECTION HEADER3. GETTING STARTED
3.1 Unpacking and Checking
Before unpacking, examine the packing case carefully for
damage. If any damage is detected, contact your distributor.
Open the package and remove the equipment and
accessories carefully. Check all materials as per the packing
list and check for any mechanical damage.
NOTE:
Save the packing case and packaging material as they can
be used if the equipment must be reshipped.
WARNINGS:
• Keep the packing material out of children’s reach. Disposal
of the packaging material should observe the applicable
waste control regulations.
• Before use, verify that the package is intact. Do not use
the Pulse Oximeter on any patient if the equipment or
package is damaged.
3.2 Environmental Requirements
The operating environment of the equipment must meet the
requirements specied in this manual.
When the equipment is moved from one place to another,
condensation may occur as a result of temperature or
humidity difference. In this case, never start the system
before the condensation disappears.
WARNING:
Make sure that the operating environment of the equipment
meets the specic requirements. The equipment may
not meet the specications dened in this manual and

Handheld Pulse Oximeter (Reorder No. 36403) 19
3. GETTING STARTED (continued)
unexpected consequences, e.g. may result in damage to the
equipment.
3.3 Connect The Sensor
1. Before use, check the Pulse Oximeter for mechanical
damage.
2. Install the alkaline batteries and ensure that the batteries
have sufcient power.
3. Plug the SpO2extension cable in the multi-functioning
connector on top of the oximeter, as shown in Fig. 3.
Ensure that the sensor is rmly plugged in.
Fig. 3
NOTE: The connector is also applied to upload data to
MedView software for reviewing. Detailed information is
referred to MedView software operator’s manual.

20 Handheld Pulse Oximeter (Reorder No. 36403)
SECTION HEADER3. GETTING STARTED (Continued)
3.4 Starting or Shutting Off the Oximeter
To start the Pulse Oximeter
1. Press and hold the Power button for 3 seconds. The LED
and alarm lamp ashes, and then goes out. The system
gives a beep and displays the startup screen. The startup
screen displays the version number of software.
2. The startup screen disappears and normal screen
appears.
To shut off the Pulse Oximeter
1. Conrm that the patient measurement is nished.
2. Disconnect the SpO2extension cable from the Pulse
Oximeter.
3. Press and hold the Power button for 4 seconds.
WARNING
Do not use the Pulse Oximeter if you suspect it is not
working properly, or if it is mechanically damaged. Contact
your distributor immediately.