KTMED OXYPALM User manual

Operator’s Manual
OXYPALM
(Ver. 1.04)
Palm Type Pulse Oximeter
012

CONTENTS
KTMED Inc. Model OXYPALM Operator’s Manual
Service/Return Policy …………………………………………………………………………………………………1
General Safety Information ……………………………………………………………………………………………3
Section 1 – Instruction
1-1 Function and Properties ……………………………………………………………………………………………7
1-2 Applications ………………………………………………………………………………………………………7
1-3 Composition ………………………………………………………………………………………………………7
1-4 Specifications ………………………………………………………………………………………………………8
Section 2 – Explanation of Panel and Controls
2-1 Main Body
2-1-1 Front Panel ……………………………………………………………………………………………………9
2-1-2 Side Panel ……………………………………………………………………………………………………10
2-1-3 Rear Panel ……………………………………………………………………………………………………10
2-1-4 Top Panel ……………………………………………………………………………………………………11
2-2 Power supply ………………………………………………………………………………………………………11
Section 3 – Preparation for Measurement
3-1 Preparations of Sensor …………………………………………………………………………………………12
3-2 Turn On/Off ………………………………………………………………………………………………………12
Section 4 - Setup
4-1 Sensor
4-1-1 Recognizing Sensor …………………………………………………………………………………………13
4-1-2 Recognizing whether a finger slips out of Sensor ………………………………………………………13
4-2 System sound volume set ………………………………………………………………………………………14
4-3 Alarm set
4-3-1 Alarm sound volume set ………………………………………………….…………………………………14
4-3-2 Alarm interval time set ………………………………………………….…………………………………15
4-4 Alarm limit set
4-4-1 SpO2 low alarm limit set ………………………………………………………….…………………………15
4-4-2 Pulse rate high alarm limit set ……………………………………………………………………………15
4-4-3 Pulse rate low alarm limit set ………………………………………………………………………………16
4-5 Time set ……………………………………………………………………………………………………………16
4-6 Data output ………………………………………………………………………………………………………19
Section 5 – Cleaning and Maintenance
5-1 Cleaning ……………………………………………………………………………………………………………20
5-2 Maintenance ………………………………………………………………………………………………………20
Appendix A – Principles of Operation
Principles of Pulse Oximeter ………………………………………………………………………………………21
Appendix B – Replacement Procedure of Rubber Case & Battery for OXYPALM ……22

SERVICE/RETURN POLICY
KTMED Inc. Model OXYPALM Operator’s Manual 1
Thank you for your choosing of OXYPALM. Please read this user’s manual carefully for proper handling
and maintenance before attempting to operate this product. And, if you don’t understand the instructions or
discover any problems concerning this product, contact us or our official sales representatives.
To ensure a safe operation and long-term performance stability, it is essential that you fully understand the
product’s functions and operating and maintenance instructions by reading this manual.
Warranty
KTMED Inc. guarantees our product to be free from any defects in the product’s workmanship and
materials under normal use and service for a period of two year from date of shipment. The KTMED’s
obligation under this warranty is limited to repairing or replacing any part which upon KTMED’s examination
proves to be defective.
KTMED’s obligation or liability under this warranty does not include anything that results from the improper
use or application of the product or any substitution involved with its parts or accessories that are approved
by KTMED Inc. or if any repairs are conducted or attempted by anyone other than a KTMED Inc. authorized
representative.
This warranty shall not extend to any product instrument that has been subjected to misuse, negligence or
accident; any instrument from which KTMED’s original serial number tag or product identification markings
have been altered or removed; or any product created by any other manufacturer.
When malfunctions of our product happen, please inform our service personnel of the basic facts, such as
product No., purchase date and a brief description of the problems.

SERVICE/RETURN POLICY
KTMED Inc. Model OXYPALM Operator’s Manual 2
Request for services
The service for a KTMED product can be performed only by the personnel authorized by our company. In
the event that our unit is serviced by an unauthorized third party or such an attempt is made during the
warranty period, the warranty shall be nullified.
When you find any problems on the unit, never open the unit but contact KTMED or our official sales
representative. If you do not, it may cause big problems that can't be covered by us.
Return Procedure
In the event that it becomes necessary to return a unit to KTMED Inc., the following procedures should be
followed:
1. Contact KTMED Inc. Service Department at 82-2-2108-7890. Please provide the model number,
serial number, and a brief description of the reason for the product’s return.
2. The customer is responsible for any freight charges, when equipment is shipped to KTMED for
servicing (this includes all customs charges).
KTMED INC. EU REPRESENTATIVE
(#610,Hanshin IT Tower,Guro-dong) Obelis s.a.
272, Digital-ro, Guro-gu, Seoul, Korea Bd. Général Wahis 53
TEL: [phone] B-1030 Brussels, Belgium
www.ktmed.com TEL. [phone]

GENERAL SAFETY INFORMATION
KTMED Inc. Model OXYPALM Operator’s Manual 3
This section contains general safety information related to use of OXYPALM. To ensure continued safe
equipment usage, carefully read the information in this section.
Warnings, cautions and notes are used throughout this manual to provide additional information to its user.
Particular attention must be paid to all warnings, cautions and notes of this manual.
※ Warning
"Warning" is used to instruct the user that if an operating procedure, practice, etc. are not followed,
personal injury may result.
z Read this manual carefully before operating the OXYPALM.
z Possible explosion hazard. Don't use this unit in the presence of flammable anesthetics.
z If OXYPALM is used with other electrical equipment such like ultrasound surgical at the same time,
it may breakdown.
※ Caution
The purpose of a "Caution" is to inform the user of an operating procedure, practice, etc. which, if not
followed, could result in minor personal injuries or possible damage to the equipment.
You should use sensors supplied by KTMED Inc. If any other device is used, it may damage to the unit.
※ Note
A “NOTE” is used to inform the user of ways to install, operate and maintain the product. This information
is important but not related to hazard.
z Inaccurate measurements may result when the sensor sites are exposed to excessive amounts of
patient movement.
z Don’t place OXYPALM sensor on the same extremity where a blood pressure cuff, an arterial line
or intra-vascular line has been placed. The occlusion of the blood flow during blood pressure
determinations may affect saturation readings.
z When you simultaneously measure blood pressure, attach the sensor to a different arm's finger as
shown in Figure 1. Do not place the sensor with NIBP cuff and catheter.

GENERAL SAFETY INFORMATION
KTMED Inc. Model OXYPALM Operator’s Manual 4
[Figure 1: Sensor placement]
z SpO2 measurements may be affected in the presence of any high-intensity light source. Do not
expose the sensor to an operating lamp, a direct X-ray light or strong light. Shield the sensor area
(with a surgical towel, for example) if necessary.
z Do not use the unit under conditions of shocks and vibrations. Do not use it, either, with the patient
connected to such medical electrical equipment as a cardiac pacemaker and other electrical
stimulators. And keep away from MRI, CT etc. It may cause burning and adversely affect MRI
measurement.
z Do not disassemble or open the unit when you find something wrong with it. Please contact KTMED
INC. or our sale representative directly. We do not charge you in this case. If you do not contact us
even after finding something wrong with the unit, you might face a complicated problem.
z Use only KTMED-supplied sensors. These sensors are manufactured to meet the accuracy
specifications for pulse oximeter. Using other manufacturers’ sensors may cause improper pulse
oximeter performance. And do not use a damaged sensor.
z Remove the manicure and any dirt from the patient’s nails.
z Follow local governing ordinances and recycling instructions regarding disposal or recycling of
device components, including batteries.
z Inaccurate measurements can be caused by :
- Incorrect application of the sensor;
- Placement of the sensor on an extremity with a NIBP cuff, arterial catheter, or intra-vascular line;
- Patient’s moving.
z Loss of pulse signal can occur for following reasons:
 Too tight sensor;
 Inflation of a blood pressure cuff on the same extremity as the one where the sensor is
attached.
 Arterial occlusion proximal to the sensor.
z This equipment generates uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to other devices in the
vicinity. However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to other devices, which can be determined by

GENERAL SAFETY INFORMATION
KTMED Inc. Model OXYPALM Operator’s Manual 5
turning the equipment off and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
- Reorient or relocate the receiving device.
- Increase the separation between the equipment.
- Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected.
- Consult the manufacturer or field service technician for help.
※ Caution
※
Warning
※ Safety Symbols
The International Electro-technical Commission (IEC) has established a set of symbols for medical
electrical equipment regarding connections or warnings of potential hazards.
The classification and symbols are shown below;
Symbol Description
Attention, consult ACCOMPANYING DOCUMENTS
Date of manufacture
Serial Number
Type BF APPLIED PART
Direct Current
Low Battery
Data Transmission
If you are uncertain about the accuracy of any measurement, check the patient's vital signs by alternate
means; then make sure the monitor is functioning correctly.
Where the integrity of the external protective conductor in the installation or its arrangement is in doubt,
equipment shall be operated from its internal electrical power source.

GENERAL SAFETY INFORMATION
KTMED Inc. Model OXYPALM Operator’s Manual 6
※ Classification
KTMED's model OXYPALM is classified as;
- OXYPALM: CLASS IIa equipment
- OXYPALM is operated with internal battery only.
- Batteries should be replaced by a qualified person. If there is no qualified person, contact the service
center.
- BF APPLIED PART
- Ordinary equipment without protection against ingress of water
- Continuous operation
- Equipment not suitable for use in presence of a flammable anesthetic mixture by standard of EN
60601-1-1(Safety of Electric Medical Equipment)
- Equipment that complies with class B for noise emission, Level B for noise immunity, per standard of
EN 60601-1-2 (Electromagnetic Compatibility Requirements)
※
Warning
※
Caution
There is a risk of explosion if the battery is replaced with an incorrect type.
Do not:
- dispose of the used batteries in fire;
- put in the batteries backwards;
- mix new and used batteries; and use other types of batteries together.
Or, there may be an explosion or a leak that can cause personal injury. Dispose of used batteries according to
the manufacture’s instructions.
The unit shall be placed far from a generator, X-ray equipment, broadcasting equipment or transmitting wires,
so as to prevent the electrical noise from being generated during the operation. When this device is near such
equipment, it can produce inaccurate measurement.

SECTION 1 – Instruction
KTMED Inc. Model OXYPALM Operator’s Manual 7
1-1 Function & Properties
OXYPALM, which KTMED Inc. makes, is a device to help monitor the changes in the physical state of a
patient by measuring the level of oxygen saturation in the blood or pulse rate with an oxygen sensor (light
sensor).
Once the sensor is connected to a patient, it works automatically and the result comes into sight at a
glance, enabling the patient to receive medical service conveniently.
OXYPALM needs no expertise to use. It is designed with the purpose that once the sensor is connected to
a patient, it works on its own, and that doctors and medical staff can analyze the result with ease.
OXYPALM stores 72hours of data and transfers the data to PC. There is PC software to analyze the data.
1-2 Applications
OXYPALM is indicated for use in measuring and displaying functional oxygen saturation and pulse rate for
neonate, pediatric and adult. OXYPALM is intended for spot-checking and continuous monitoring in hospital,
clinics, ambulatory, home and EMS (Emergency medical service) environment.
1-3 Composition
OXYPALM is composed of Main body (indicator and adjuster), sensor and other related peripherals. The
sensor includes two sources of light and one light detector.
[Figure 2]

SECTION 1 – Instruction
KTMED Inc. Model OXYPALM Operator’s Manual 8
①OXYPALM main unit: 1ea
②SpO2 reusable sensor for adult: 1ea
③ AA Battery: 4ea
④ Rubber Case:1ea
⑤Operator’s Manual:1ea
1- 4 Specifications
SpO2 (%)
Pulse rate (bpm)
Measuring range 25 ~ 255bpm
Accuracy ±1%
High alarm limit 35 ~ 255 bpm, 5bpm/step
Low alarm limit 30 ~ 250 bpm, 5bpm/step
Indicator
General Condition
Maximum consumption power 20VA
Weight 250g(main body + batteries)
120g(main body)
Operating temperature 0 to ~ +50℃
Storage temperature -20℃~ +60℃
Humidity 10% ~ 95% (non-condensing)
Battery specification Sanyo 4pcs(AA), internal
Battery running life 20hours(non-stop working)
Measuring range 0-100%
Accuracy
±1% (90-100%)
±2% (80-89%)
±3% (65-79%)
Unspecified (below 64%)
Low alarm limit 85 ~ 99%, 1%/step
Yellow 10-Bar LED 1 Pulse rate
Red 7-Segment 2 SpO2, Pulse rate
LED to indicate equipment state 1 Low Battery, exceeding alarm limit

SECTION 2 – Explanation for Panal and controls
KTMED Inc. Model OXYPALM Operator’s Manual 9
2-1 Main Body
2-1-1 Front Panel
[Figure 3]
①Sensor socket: It is used to connect the sensor.
②Oxygen saturation display: It indicates how concentrated oxygen saturation is.
③Pulse rate saturation display: It shows the pulse rate per minute.
④Indicator of alarm silence: It indicates the alarm silence. If you press button, green LED blinks.
⑤Indicator: It is on when the batteries are low.
⑥Menu Button: It is used to adjust system volume, alarm interval time, alarm range, and time.
⑦ Power Button: It is used to turn on/off the power in the main body.
⑧Indicator of pulse rate magnitude: It indicates the pulse rate of a patient. The magnitude of the
indicator shows how strong the patient’s heart beats.

SECTION 2 – Explanation for Panal and controls
KTMED Inc. Model OXYPALM Operator’s Manual 10
2-1-2 Side Panel
[Figure 4]
①Sensor socket: It is used to connect the sensor.
②Battery case cover: It is the case for batteries to be built in.
2-1-3 Rear Panel
[Figure 5]
①Sensor socket: It is used to connect the sensor.
②Battery case cover: It is the case for batteries to be built in.

SECTION 2 – Explanation for Panal and controls
KTMED Inc. Model OXYPALM Operator’s Manual 11
2-1-4 Top Panel
[Figure 6]
①Sensor socket: It is used to connect the sensor.
2-2. Power supply
OXYPALM can be powered by 4 AA-size Sanyo batteries. With the 4 batteries, it works non-stop for 20
hours.
Change the batteries as shown in Figure 7. Be sure to insert the batteries in the correct position, as
indicated by the polarity markings in side the battery compartment. If batteries are positioned incorrectly, the
device might be breakdown.
[Figure 7] Installing batteries in the OXYPALM

SECTION 3 – Preparation for Measurement
KTMED Inc. Model OXYPALM Operator’s Manual 12
3-1 Preparation of Sensor
Connect the sensor with its extension cable and connect opposite of the extension cable with sensor
socket on the top of the device.
※ Caution
Please check the compatibility of sensors with KTMED Inc. or our representative other than those KTMED
Inc. supplies in case those should be used.
3-2 Turn on/ off
Turn on the OXYPALM by pressing and holding the on/off button on the front of the unit for 2seconds.
Turn off the unit by pressing and holding the on/off button on the front of the unit for 2seconds. FND is
indicated as shown [Figure 8] and the power goes off.
[Figure 8]
Initial display
When turn on the device, all indicators are turned on for 3seconds as shown [Figure 9].
Please check that all indicators are turned on. If an indicator is not turned on, breakdown should be
considered. In this case, please contact with KTMED Inc directly or our representatives.
[Figure 9]

SECTION 4 – Setup
KTMED Inc. Model OXYPALM Operator’s Manual 13
4-1 Sensor
4-1-1 Recognizing Sensor
When the power is on but the sensor is unconnected, a message as shown [Figure 10] comes up.
[Figure 10]
4-1-2 Recognize whether a finger slips out of Sensor
If the sensor is connected while a finger slips out of it, windows of SpO2 and Pulse rate show 0, a pulse
rate searching lamp is on.
[ Figure 11]

SECTION 4 – Setup
KTMED Inc. Model OXYPALM Operator’s Manual 14
4-2 System sound volume set
Press button about 2 seconds, and use button to display as [Figure 12]. If you want to adjust
system sound volume, press . You can set the system sound volume from 0 to 10.
[Figure 12]
※ Caution
OXYPLAM’s menus are not round type. In other words, menus navigate from first menu to SEn OPn
(measurement mode) on forward direction. Then it moves to measurement mode. If you want to call
back previous menu, press about 2 seconds. And you can set each menu again.
4-3 Alarm set
4-3-1 Alarm sound volume set
Press button about 2 seconds, and use button to display as [Figure 13]. If you want to adjust
alarm sound volume, press . You can set the alarm sound volume from 1 to10.
[Figure 13]

SECTION 4 – Setup
KTMED Inc. Model OXYPALM Operator’s Manual 15
4-3-2 Alarm interval time set
Press button about 2 seconds, and use button to display as [Figure 14]. If you want to adjust
system sound volume, press . You can set the alarm interval time OFF, 30, 60, 90, 120 min.
[Figure 14]
4-4 Alarm limit set
※ Default setting alarm
4-4-1 SpO2 low alarm limit set
Press button about 2 seconds, and use button to display as [Figure 15]. If you want to adjust
SpO2 low alarm limit, press . You can set the SpO2 low alarm limit from 85 to 99. (1% / 1step)
[Figure 15]
4-4-2 Pulse rate high alarm limit set
Press button about 2 seconds, and use button to display as [Figure 16]. If you want to adjust
Pulse rate high alarm limit, press . You can set the pulse rate high alarm limit from 35 to 255. (5bpm/
1step)
Parameter List High limit Low limit
SpO2 (%) - 85
Pulse Rate(bpm) 170 40

SECTION 4 – Setup
KTMED Inc. Model OXYPALM Operator’s Manual 16
[Figure 16]
4-4-3 Pulse rate low alarm limit set
Press button about 2 seconds, and use button to display as [Figure 17]. If you want to adjust
Pulse rate low alarm limit, press . You can set the pulse rate low alarm limit from 30 to 250. (5bpm/
1step)
[Figure 17]
4-5 Time set
Press and hold the menu button , while pressing and releasing the on /off button .Display shows as
shown in [Figure 18].
Sequence of time set is year, month, day, hour, and minute.
Change the value with menu button , press on/off button when the desired value appears to
advance to the next sequential setting.

SECTION 4 – Setup
KTMED Inc. Model OXYPALM Operator’s Manual 17
[Figure 18] Year
[Figure 19] Month
[Figure 20] Day

SECTION 4 – Setup
KTMED Inc. Model OXYPALM Operator’s Manual 18
[Figure 21] Time
[Figure 22] Minute
[Figure 23] Second