For this manual, the issued Date is October 2005 (Version: 1.5).
Safety Symbols
Warning
A Warning indicates that failure to follo w proper instructions can cause
death or injury to the patient, the operator, or serious damage to the
equipment.
Caution
A Caution indicates that fail ure to foll ow proper i nstructions may caus e
serious injury to the patient, the operator, or may cause damage to the
equipment.
Note
A Note is an indication of supplemental information to the operation, or
handling, of the equipment, or associated accessories.
This symbol indicates type BF applied part according to IEC 60601-1.
This symbol indicates the dual-purpose socket can connect with the PC
communication cable.
Illustrations
All illustrations in this manual are provided as examples only . They may
not necessarily reflect your setup or data displayed on your Pulse
Oximeter.
Appendix A Specifications.................................................................. 50
II
Chapter 1 Safety Information
This chapter contains important safety information related to general
use of the Pulse Oximeter. Other important safety information appears
throughout the manual in sections that relate specifically to the
precautionary information.
Note
Important! Before use, carefully read this manual, all safety
information and specifications.
This device is not intended for home use.
Federal Law (USA) restricts this device to sale by or on the order of
a physician.
The Pulse Oximeter complies with Class-A requirements of the
EN55011 standard.
Warning
This device is not intended as a device used for treatment
purposes.
It is important for the hospital or organization that uses this
equipment to carry out a reasonable maintenance schedule.
Failure to do so may result in equipment failure, or injury to the
patient or operators.
The Pulse Oximeter is intended only as an adjunct in patient
assessment. It must be used in conjunction with clinical signs and
symptoms.
1
Safety Information
Warning
The Pulse Oximeter is to be operated onl y by medical doctors or
trained healthcare personnel to measure the SpO2 of clinical
patients (including adult, pediatric and neonatal patients) in
hospitals and healthcare agencies or in the process of transporting
patients.
The Pulse Oximeter is designed for real-time and rapid
measurement of the patient’s SpO2. It is not suitable for long-time
continuous patient monitoring. Continual measurement must not
exceed 2 hours.
Before using the Pulse Oximeter, the user should check and make
sure the device and its accessories can work properly and safely.
When using the Pulse Oximeter together with the electrical surgery
equipment, the user should pay attention to and guarantee safety
of the patient being measured.
To avoid fire or explosion hazards, do not use the Pulse Oximeter
at places where such flammable material as anesthesia gas is
present.
Do not pull or lift the Pulse Oximeter by its connection cable. T hat
may lead to device falling and consequent patient injuries.
It is not recommended to hang the Pulse Oximeter when
transporting patients. Safety hazards may arise from the large
amplitude swing during the transportation.
Do not use the Pulse Oximeter or its sensor around working MRI
equipment. Induction current may lead to damages. The device
may affect operation of MRI equipment and vice versa.
The Pulse Oximeter and its accessories may be contaminated by
microorganism during transporting, use and storage. Use the
2
Safety Information
recommended methods to sterilize and disinfect the Pulse
Oximeter or its accessories when the packing material is damaged,
or it has not been used for a long time.
Caution
The Pulse Oximeter should be appropriatel y placed. Keep it from
falling, strong vibration or other mechanical damage.
The Pulse Oximeter is a commonly sealed device. The user should
keep its surface dry and clean, and prevent any liquid from
infiltrating it.
Don’t use mobile phones around when the Pulse Oximeter is in
operation.
The Pulse Oximeter should only be maintained by personnel
approved by our company.
Before use the Pulse Oximeter on patients, the user should be
familiar with its operation.
3
FOR YOUR NOTES
Safety Information
4
Chapter 2 General
2.1 Introduction
The Pulse Oximeter is a portable measuring device powered by
common or rechargeable batteries. It is compact, light, flexible to use
and easy to learn.
Parameters measured by the Pulse Oximeter include: arterial oxygen
saturation (SpO
Oximeter measures these parameters through a SpO
displays them on the LCD screen after certain further processing.
The Pulse Oximeter is operated and controlled by three buttons, which
are Power button, Backlight button and Confirm ID button. The Pulse
Oximeter is also capable of managing measured data and transmitting
the patient’s trend through the dual-purpose socket to a PC for printing.
), pulse rate (PR) and pulse strength. The Pulse
2
sensor and
2
2.2 Functions
The Pulse Oximeter has the following functions:
Measuring: SpO
Prompting: Memory full, ID full, low battery, standby, and
technical error etc.
Power managing: automatic standby, automatic shutdown;
Data Managing: data storage, data protection, data deletion;
Data Printing: patient information and trend data;
For the data printing function, you must install the Pulse Oximeter
management system in a PC equipped with a printer, and connect the
Pulse Oximeter with the PC by a communication cable.
, PR and pulse strength;
2
5
2.3 Appearance
General
①
②
③
④
⑤
⑥
⑦
⑧
Figure 2-1 Front Panel Figure 2-2 Back Panel
Table 2-1 Appearance description
No. Description Remarks
Dual-purpose
①
socket
LCD It displays information listed in Table 2-2.
②
Power It turns on or off the device.
③
Confirm ID It confirms the patient ID for current measurement.
④
Delete ID
⑤
Backlight It turns on or off the backlight.
⑥
⑦
⑧
Battery door Open it to install or remove batteries.
It connects SpO2 sensor or PC communication cable.
A key combination of ④ and ⑥.
Caution. Refer to this manual.
6
General
2.4 Displayed Information
Figure 2-3 shows information displayed on the LCD screen.
①
②
⑤
⑥
③
⑦
④
Figure 2-3 Displayed Information
Table 2-2 Description of displayed information
No. Description Remarks
ID number It displays current ID number ranging from 000 to 100
①
ID Full
②
Memory Full It appears when previous data is to be covered by
③
Pulse StrengthIt can display 7 segments at most to indicate real time
④
It displays “%SpO2”.
%SpO
⑤
⑥
⑦
⑧
⑨
2
value It displays SpO2 value and is refreshed every second.
SpO
2
PR It displays “PR”.
PR value It displays PR value and is refreshed every second.
Low battery It appears only when the battery energy is low.
It appears when ID≥95 and blinks when stored ID is
being covered by new ID.
new data. Please refer to 5.1.1 Data Storage.
pulse strength.
Unit: bpm (beats per minute)
⑧
⑨
Please refer to Chapter 3 Installation for displayed information of
startup and standby modes.
7
General
2.5 Button Operation
Three soft buttons are available on the front panel.
Power Backlight Confirm ID
Figure 2-4 Buttons
2.5.1 Power Button
Power-on: Press to turn on the device.
Power-off: Press and hold for two seconds to turn off the device.
Note
The Pulse Oximeter is powered by batteries only. Please install
batteries before use according to the descriptions in 3.2 Install Batteries.
In case the SpO2 cable becomes disconnected or the finger moves
away from the sensor, the Pulse Oximeter will automatically enter
the standby mode. Under this mode, when a finger is inserted into
the sensor, the Pulse Oximeter will automatically resume the
operation mode. Otherwise, if no finger is inserted in 5 minutes, the
Pulse Oximeter will be automatically shut down.
2.5.2 Backlight Button
Backlight on: Press the Backlight button to turn on backlight.
Backlight off: Press the Backlight button to turn off backlight.
8
General
2.5.3 Confirm ID Button
The Confirm ID button is used to add data. It enables the user to add
data, without using a new ID number, to a re-test for the same patient
after the sensor is accidentally disconnected.
Refer to section 5.1 Data Management for detailed use of this button.
2.5.4 Delete ID Button
The Delete ID button is a key combination of the Backlight button and
the Confirm ID button.
Refer to section 5.1 Data Management for detail use of this button.
9
FOR YOUR NOTES
General
10
Chapter 3 Installation
3.1 Unpacking and Inspection
Please carefully remove the Pulse Oximeter and its accessories from
the package and check items by comparing them to the packing list.
Check the device for any mechanical damages.
Check all cables and accessories for damage.
In case of any problem, please contact our Customer Service.
Note
Please save all packaging materials for future transportation or
storage use.
Warning
The user should keep the packing materials at places out of
children’s reach. Before disposing the packing materials, check
with your local waste officials for details in your area for recycling
options or proper disposal.
3.2 Install Batteries
The Pulse Oximeter is powered by four batteries. Follow the steps
below to install batteries before use:
1. Hold the Pulse Oximeter in one hand.
2. Place the other hand on the battery cover.
3. Push the cover away as Figure 3-1 shows.
4. Place batteries into the slots per the “+” and “-” indications as
11
Installation
shown in Figure 3-2.
5. Push back the battery cover.
Note
Before disposing of the battery, check with your local solid waste
officials for details in your area for recycling options or proper
disposal.
Caution
Please use AA alkaline batteries or rechargeable batteries. Do not
use carbon or poor quality batteries. Remove the batteries if the
device is not to be used for a long time.
During use, replace batteries of insufficient energy in time with
good ones; abnormal power supply may lead to product damages
or even personnel injuries.