Gima PC-900 User Manual

PROFESSIONAL MEDICAL PRODUCTS

Gima S.p.A. - Via Marconi, 1 - 20060 Gessate (MI) Italy
Italia: tel. [phone] - fax [phone]
Export: tel. [phone]/221/225 fax [phone]
[e-mail] - [e-mail]

www.gimaitaly.com

GIMA VITAL-SNT MONITOR

User Manual

0123

Fabbricante/Manufacturer:
Shenzhen Creative Industry Co., Ltd. 2/F Block 3 Nanyou Tian’an Industry Town
518054 Shenzhen, GD - P.R.C.

Shanghai International Trading Corp. GmbH (Hamburg)
Eiffestrasse 80, 20537 Hamburg - Germany

ATTENTION: The operators must carefully read and completely understand
the present manual before using the product

M35121-M-Rev.0.05.11

-I-

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 State Technological Supervision

Bureau. The Manual is written for the current PC-900 Vital Signs 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.

Version of This Manual: Ver1.0

October 20, 2010

Copyright © 2010 Shenzhen Creative Industry Co., Ltd.

All rights reserved.

Marks in the Manual:

 Warning: must be followed to avoid endangering the operator and the

patient.

 Attention: must be followed to avoid causing damage to the monitor.

 Note: some important information and tips about operations and

application.

-II-

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.

 Monitoring a single person at a time.

 Disconnect the monitor and sensors before MRI scanning. Use during

MRI could cause burns or adversely affect the MRI image or the
monitor’s accuracy.

 If you have any doubt to the grounding layout and its performance, you

must use the built-in battery to power the monitor.

 All combinations of equipment must be in compliance with IEC Standard

60601-1-1 systems requirements.

 Check SpO

2

probe application site periodically (every 30 minutes) to

determine circulation, positioning and skin sensitivity.

 The SpO

2

measurement of this monitor may not work for all testees. If

stable readings can not be obtained at any time, discontinue use.

 Do not immerse the monitor or its accessories in liquid to clean.

 Do not use accessories other than those provided/recommended by the

manufacturer.

 Each time the monitor is used, check the alarm limits to ensure that they

are appropriate for the patient being monitored.

 The monitor is intended only as an adjunct in patient assessment. It

must be used in conjunction with clinical signs and symptoms.

 Continuous use of SpO

2

sensor may result in discomfort or pain, especially for
those with microcirculatory problem. It is recommended that the sensor should

NOT be applied to the same place for over two hours, change the measuring site
periodically if necessary.



SpO2 measuring position must be examined more carefully for some special

patient. Do NOT install the SpO

2

sensor on the finger with edema or vulnerable

tissue.

-III-

 DO NOT stare at the infrared light of SpO2 sensor when switch it on, for the

infrared may do harm to the eye.



Do not use this device in an environment with ignitable or inflammable gas.

 When taking the measure of an infant’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.

 The monitor is prohibited from applying to those who have severe hemorrhagic

tendency or who are with sickle cell disease for they may develop partial bleeding
when this monitor is used to take the blood pressure measurement.

 DO NOT take blood pressure measurement from a limb receiving ongoing

transfusion or intubations or skin lesion area, otherwise, damages may be caused
to the limb.



Do not place the monitor in any position that may cause it to fall on the
patient.

 Check the safety and performance of this monitor every time before using

it to ensure it works normally and safely

 Ensure the monitor is grounded reliably before using it, if the integrity of

grounding connection is in doubt, the monitor should work by using the
built-in battery.

 Turn off the monitor and take away the sensors from the patient during

MRI scanning. Otherwise it may cause burn to the patient and the quality
of MRI image or the measurement accuracy of the monitor may be
affected.

 Although biocompatibility tests had been done to 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 hoses of the applied parts should be kept away from the

patient’s neck to prevent any possible choke 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 performance have been carefully tested and positive testing results
obtained.



Please peruse the relative content about the clinical restrictions and

contraindication.

-IV-



When disposing of the monitor and its accessories, the local law should be
followed.

-V-

Table of Contents

CHAPTER 1 OVERVIEW................................................................................................. 1

1.1 F

EATURES....................................................................................................................................... 1

1.2 P

RODUCT NAME AND MODEL ........................................................................................................... 1

1.3 I

NTENDED USE ................................................................................................................................1

1.4 S

YMBOLS ON THE MONITOR............................................................................................................. 2

1.5 S

AFETY........................................................................................................................................... 2

CHAPTER 2 OPERATING PRINCIPLE........................................................................... 3

2.1 O

VERALL STRUCTURE...................................................................................................................... 3

CHAPTER 3 INSTALLATION AND CONNECTION........................................................ 4

3.1 A

PPEARANCE .................................................................................................................................. 4

3.1.1 Front Panel............................................................................................................................. 4

3.1.2 Side Panel .............................................................................................................................. 6

3.1.3 Rear Panel.............................................................................................................................. 7

3.2 I

NSTALLATION.................................................................................................................................. 8

3.2.1 Opening the Package and Check.......................................................................................... 8

3.2.2 Connecting the Power Supply ...............................................................................................8

3.2.3 Starting the Monitor ............................................................................................................... 8

3.3 S

ENSOR PLACEMENT AND CONNECTION ........................................................................................... 9

3.3.1 Blood Pressure Cuff Connection ........................................................................................... 9

3.3.2 SpO

2

Sensor Connection..................................................................................................... 11

3.3.3 TEMP Transducer Connection ............................................................................................ 12

3.3.4 Loading printing paper ........................................................................................................ 12

3.3.5 Battery Installation ............................................................................................................... 13

CHAPTER 4 OPERATIONS .......................................................................................... 15

4.1 I

NITIAL MONITORING SCREEN ......................................................................................................... 15

4.1.1 Default Display Screen Description ..................................................................................... 15

4.1.2 Operation Instructions ......................................................................................................... 16

4.2 S

PO2 MONITORING SCREEN........................................................................................................... 17

4.2.1 Screen Description .............................................................................................................. 17

4.2.2 Operation Instructions ......................................................................................................... 18

4.3 T

REND GRAPH DISPLAY ................................................................................................................. 18

4.3.1 Screen Description .............................................................................................................. 18

4.3.2 Operation Instructions ......................................................................................................... 19

4.4 NIBP L

IST SCREEN ....................................................................................................................... 19

4.4.1 Operation Instructions ......................................................................................................... 20

4.5 S

ETUP MENU SCREEN ................................................................................................................... 20

4.5.1 ECG and Temperature Setup .............................................................................................. 21

-VI-

4.5.2 SpO2 Setup .......................................................................................................................... 21

4.5.3 NIBP Setup .......................................................................................................................... 22

4.5.4 Nurse Call............................................................................................................................. 24

4.5.5 System Setup....................................................................................................................... 25

4.5.6 Patient Info ........................................................................................................................... 26

4.5.7 Date/Time............................................................................................................................. 26

4.5.8 Recover Default Settings ..................................................................................................... 26

4.6 P

OWER SAVING MODE................................................................................................................... 27

CHAPTER 5 ALARM..................................................................................................... 28

5.1 A

LARM PRIORITY ........................................................................................................................... 28

5.2 A

LARM MODES .............................................................................................................................. 28

5.3 A

LARM SILENCE ............................................................................................................................ 29

5.4 A

LARM SETTING ............................................................................................................................ 29

5.5 V

ERIFY ADJUSTABLE ALARM FUNCTION .......................................................................................... 29

CHAPTER 6 TECHNICAL SPECIFICATIONS .............................................................. 31

6.1 NIBP M

ONITORING ....................................................................................................................... 31

6.2 S

PO2 MONITORING........................................................................................................................ 31

6.3 P

ULSE MONITORING...................................................................................................................... 31

6.4 TEMP M

ONITORING...................................................................................................................... 32

6.5 D

ATA RECORDING ......................................................................................................................... 32

6.6 O

THER TECHNICAL SPECIFICATIONS ............................................................................................... 32

6.7 O

PERATING ENVIRONMENT............................................................................................................. 32

6.8 C

LASSIFICATION ............................................................................................................................ 32

6.9 M

ANUFACTURER’S DECLARATION................................................................................................... 33

CHAPTER 7 PACKAGING AND ACCESSORIES......................................................... 37

7.1 P

ACKAGING .................................................................................................................................. 37

7.2 A

CCESSORIES ............................................................................................................................... 37

CHAPTER 8 WORKING PRINCIPLE............................................................................ 39

8.1

NIBP MONITORING ....................................................................................................................... 39

8.1.1 Measuring Principle ............................................................................................................. 39

8.1.2 Factors affecting NIBP measuring....................................................................................... 40

8.1.3 Clinical Limitations............................................................................................................... 41

8.2 S

PO2 MONITORING........................................................................................................................ 42

8.2.1 Measuring Principle ............................................................................................................. 42

8.2.2 SpO

2

Measurement Restrictions (interference reason) ....................................................... 42

8.2.3 Low SpO

2

measuring value caused by pathology reason .................................................. 42

8.2.4 Clinical Limitations............................................................................................................... 43

8.2.5 Points to be noted in SpO

2

and Pulse Measuring............................................................... 43

CHAPTER 9 TROUBLESHOOTING..............................................................................45

-VII-

9.1 NO DISPLAY ON THE SCREEN ......................................................................................................... 45

9.2 N

O BLOOD PRESSURE AND PULSE OXYGEN MEASURES .................................................................. 45

9.3 B

LANK PRINTING PAPER ................................................................................................................ 45

9.4 S

YSTEM ALARM............................................................................................................................. 45

CHAPTER 10 MAINTENANCE ..................................................................................... 46

10.1 S

ERVICE AND EXAMINATION.......................................................................................................... 46

10.1.1 Daily Examination .............................................................................................................. 46

10.1.2 Routine Maintenance ......................................................................................................... 46

10.1.3 Battery Maintenance.......................................................................................................... 46

10.1.4 Service ............................................................................................................................... 47

10.2 C

LEANING, STERILIZATION AND DISINFECTION ............................................................................... 47

10.3 C

LEANING, STERILIZATION AND DISINFECTION OF ACCESSORIES .................................................... 48

10.4 S

TORAGE .................................................................................................................................... 48

10.5 T

RANSPORTATION ....................................................................................................................... 48

CHAPTER 11 APPENDIX..............................................................................................49

11.1 P

ROMPT INFORMATION EXPLANATIONS.......................................................................................... 49

11.2 D

EFAULT ALARMING VALUES AND SETUP RANGE........................................................................... 50

11.3 A

CCESSORIES LIST ...................................................................................................................... 50

11.4 I

NSTRUCTIONS FOR SPO2 PROBE ................................................................................................. 51

-1-

Chapter 1 Overview

1.1 Features



Blood Pressure, SpO

2

and Pulse Rate are displayed by big, bright digital LEDs;



SpO

2

plethysmogram and system parameters are displayed on dot matrix LCD screen;



Accurate NIBP measurement

with hardware and software over-pressure

protection;



Unique SpO

2

measuring technique ensures sensitive and accurate SpO2, Pulse Rate

and Perfusion Index measurement;



SpO

2

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;



With tourniquet function;



NIBP measurement is applicable to adult and pediatric by patient selection;



Built-in printer is optional to print out waveforms, and text information.

1.2 Product Name and Model

Name: Vital Signs Monitor

Model: PC-900

1.3 Intended Use

This Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of
adult and pediatric patients. With the functions of real-time recording and displaying parameters,
such as ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, body
temperature, and so on, it allows comprehensive analysis of patient’s physiological conditions.

This instrument is applicable for use in hospitals and clinical institutions. The operation should be

performed by qualified professionals only.

-2-

1.4 Symbols on the Monitor

Adult Patient



Waveform Freeze

Pediatric Patient

Pulse sync indicator (Reserved)

Reserved

Setup Menu

NIBP Start/Cancel



AC Power

Alarm Silence

DC Power

Print

Type BF applied part

 Up

Type CF applied part with

defibrillator protection



OK

Warning, refer to User Manual.



Down

Equal potential terminal

ECG Lead Selection

(Reserved)

Nurse call output

1.5 Safety

a) Conform to IEC60601-1, certified as Class I, with Type BF and CF applied parts.

b) It can resist against defibrillator and electrosurgical equipment interferences, and can

work with pace-maker as well. This equipment is suitable for use in the presence of
electrosurgery.

-3-

Chapter 2 Operating Principle

2.1 Overall Structure

The overall structure of the monitor is shown in Fig. 2.1.

Figure 2.1

PC-900 Vital Signs Monitor is module designed product; it consists of TEMP module, NIBP module,

SpO

2

module, main control unit, printer module, display panel, and power supply block etc.

1. TEMP module measures temperature with temperature probe.

2. The SpO

2

module detects and calculates pulse rate and oxygen saturation (SpO2), and

provides plethysmogram and perfusion index as well.

3. 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 and pediatric respectively.

4. The main control unit is in charge of LED and LCD display, keyboard input, data storage,

printing, and networking function.

-4-

Chapter 3 Installation and Connection

3.1 Appearance

3.1.1 Front Panel

Figure 3.1 Front panel illustration

Description:

1 Alarm indicator

Indicator Alarm Level

Alarm Event

Red flashing

High priority alarm

Exceeding the limits, low battery voltage

Orange Medium priority alarm

Leads or probe off

Green light

Normal

-5-

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 NIBP

measurement; they will be displayed alternately. The format of NIBP measuring time is

“hh:mm”. If the tourniquet is in use, the cuff pressure will be displayed here.

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

HR(priority indicator): HR indicator (Reserved function);

6

Display PR value: when the set of “Setup Menu Systempriority” is “PR”, it shows PR

value.

7

PR(priority indicator): when PR indicator is on, it indicates that the numerical value

beside is pulse rate value; Unit: “bpm (beats per minute)”.

8

SpO2: Display SpO2 value; Unit: “%”

9

“ ”: Bar-graph of pulse intensity

10

LCD panel

11

Pulse sync indicator patient category indicator: “ ” for adult; “ ” for pediatric; Patient

category is selected under sub-menu “Patient Info” within the setup menu.

12

Pulse sync indicator: pulse sync indicator, its flashing is synchronized with pulse.

13

NIBP: start/cancel NIBP measurement

14

Alarm silence key: set or activate the system alarm. In the monitoring screen, press

“Alarm” to set the alarm timer. There are four options of alarm silent time: 2 minutes, 5

minutes, 10 minutes and 20 minutes. The time shows up on the upper left corner of the

screen. When the alarm timer is activated, the system begins to count down. If alarm

occurs during that period, the system alarm will be actived automatically and the monitor

will give alarm. If there is no alarm during that period, when the set time has passed the

system alarm will be actived as well.

This key will be disabled when the system volume is set as “0”.



DO NOT silence the audible alarm or decrease its volume if patient
safety could be compromised.

15 Alarm silence indicator: When it is on, it indicates that the monitor stays in alarm silence

status or it indicates that the alarm is off when the system volume is “0”.

16

Print: the internal printer is optional, press this key to print the current measuring

data;

-6-

17



Up: shift cursor forward/upward

18



OK: to confirm selection or modification

19



Down: shift cursor backward/downward

20

Display: shift LCD display modes

21



Waveform Freeze: freeze the current displayed waveform.

22

ECG Lead Selection (Reserved function)

23



: AC Power indicator

24

: DC Power indicator

AC Power

indicator

DC Power indicator

Descriptions

ON (green)

ON (green)

this device is using mains power supply

ON (green)

ON (orange)

this device is using mains power supply

and the battery is being recharged.

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.

Status

ON (green)

OFF

the battery is being recharged while the
device is off

25

: 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).

26 SpO2: SpO2 sensor connector

27

NIBP: NIBP hose connector

28 TEMP: TEMP probe connector

29 ECG: ECG cable connector (reserved)

3.1.2 Side Panel

The built-in thermal printer is in the left panel. It is easy for user to print waveform and data.

-7-

3.1.3 Rear Panel

Figure 3.2 Rear Panel

Introduction to the rear panel:

1

Handle

2 Fan

3 Nameplate

CE mark

Serial number

Date of manufacture

Authorised representative in the European community

Manufacturer (including address and date)

Disposal of this device according to WEEE regulations

4 “FUSE T3.15 A”: Fuse holder. Fuse specification: T3.15AL/250V 520mm.

5 “AC100~240V” : AC power supply socket

6 Loudspeaker

7 Mounting hole for hanging the monitor

8 NET: serial communication port which is used to network with central monitoring system

(optional);

9 Nurse-call connector

10

: Equipotential ground terminal

-8-

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

 You can customize the module configuration by choosing necessary modules to meet

your own needs. Therefore, your monitor may not have all the monitoring functions and

accessories.

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 power supply is 100-240VAC, 50/60Hz.

 Use the power cable prepared by the manufacturer. Insert one end of it to the power

port of the monitor and the other end to the grounded three-phase power jack.

 To eliminate potential differences, the monitor has a separate connection to the

equipotential grounding system. Connect one end of the provided ground cable to

equipotential grounding port on the rear of the monitor, and connect the other end to
one point of the equipotential grounding system.

Caution: ensure that the monitor is grounded correctly.

 After the supply mains has been interrupted when power switch remains in the “on”

position and is restored after a period of time that is longer than 30 seconds, the monitor
will run by the last settings when restarting the monitor.

2. When powered by built-in battery

 Caution: it’s better to recharge the battery after it is used up, the charging time

should be 13~15 hours long.

 The provided battery of the monitor must be recharged after transportation or

storage. So if the monitor is switch on without being connected to the AC power
socket, it may not work properly due to insufficient power supply.

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.

-9-

 If the battery is applied please recharge it after using the monitor to ensure sufficient

power storage. It will take minimal 8 hours to charge battery from depletion to 90%
charge.



Do not use the device to monitor the patient if there are indications of damage or reminders of

error. Please contact the local dealer or our company.



It’s recommended to delay 1 minute to start it again.

3.3 Sensor Placement and Connection

3.3.1 Blood Pressure Cuff Connection

1. Connect the cable to the right-panel connector marked with the NIBP icon.

2. Unveil and wrap the cuff around patient’s upper arm.

Requirements of the cuff:

1) Appropriate cuff should be selected 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:

Note: The size of the cuff selected should suit the subjects while measuring.

Cuff Model

Arm Cuff

Small-sized Pediatric 6cm11cm

4.5cm

Middle-sized 10cm19cm

8cm

Large-sized Pediatric 18cm26cm

10.6cm

Adult Cuff

25cm35cm

14cm



When putting on the cuff, unveil and wrap it around the upper arm evenly to appropriate
tightness.

2) Remember to empty the residual air in the cuff before the measurement is commenced.

3) Locate the cuff in such a way that the “” mark is at a location where the clearest pulsation
of brachial artery is observed.

4) The cuff should be tightened to a degree where insertion of one finger is allowed.

5) The lower end of the cuff should be 2cm above the elbow joint.

-10-

Figure 3.3 Cuff Placement

Safety Instructions for NIBP Monitoring

 When taking the measurement of an infant’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.

 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 or pediatric) 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.

 The time of the automatic pattern noninvasive blood pressure measurement pull too

long, then the body connected with the cuff possibly have the purpura, lack the

blood and the neuralgia. When guarding patient, must inspect the luster, the warmth

and the sensitivity of the body far-end frequently. Once observes any exception,

please immediately stop the blood pressure measurement.



The subject should lie on the back so that the cuff and the heart are in a horizontal

position and the most accurate measure is taken. Other postures may lead to inaccurate
measurement.



Do not speak or move before or during the measurement. Care should be taken so that

the cuff will not be hit or touched by other objects.



The measures should be taken at appropriate intervals. Continuous measurement at too
short intervals may lead to pressed arm, reduced blood flow and lower blood pressure,

and resulting inaccurate measure of blood pressure. It is recommended the measure be
taken at intervals of more than two minutes.

 When an adult subject is monitored, the machine may fail in giving the blood pressure

measure if the infant mode is selected.

 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.

The symbol indicates that the cable and accessories are designed to have special

-11-

protection against electric shocks, and is defibrillator proof.

3.3.2 SpO2 Sensor Connection

SpO2 sensor is a very delicate part. Please follow the steps and procedures in operating it. Failure

to operate it correctly can cause damage to the SpO

2

sensor.

Operation procedure:

1. Connect the SpO

2

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 SpO

2

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 SpO

2

sensor placement

When selecting a sensor, consider the patient’s category, adequacy of perfusion, availability of

probe site and anticipated monitoring duration. Use only SpO

2

probes provided by our company

with this monitor. Read the following table for SpO

2

probe information. Refer to Chapter 11.4 for

the detailed instructions of each SpO

2

probe.

Part No. SpO

2

Probe Patient Category

15044041 SpO2 Finger clip Sensor (reusable) Pediatric

15044038 SpO2 Finger rubber Sensor(reusable) Adult

15044034 SpO2 Finger clip Sensor(reusable) Adult

High ambient light sources such as surgical lights (especially those with a xenon light source),
bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the

performance of a SpO

2

sensor. To prevent interference from ambient light, ensure that the sensor

is properly applied, and cover the sensor site with opaque material.

Failure to take this action in high ambient light conditions may result in inaccurate measurements.

If patient movement presents a problem, verify that the sensor is properly and securely applied;

move the sensor to a less active site; use an adhesive sensor that tolerates some patient motion;
or use a new sensor with fresh adhesive backing.

For reusable sensors, follow the sensor directions for use for cleaning and reuse. For single-patient

-12-

use sensors, use a new sensor for each patient. Do not sterilize any sensor by irradiation, steam, or
ethylene oxide.

Safety Introductions for SpO

2

Monitoring

 Continuous use of SpO

2

sensor may result in discomfort or pain, especially for those

with microcirculatory problem. It is recommended that the sensor should NOT be
applied to the same place for over two hours, change the measuring site periodically

if necessary.

 SpO

2

measuring position must be examined more carefully for some special patient.

Do NOT place the SpO

2

sensor on the finger with edema or fragile tissue.

 If sterile packaging of SpO

2

sensor is damaged, do not use it any more.

 Check the SpO

2

sensor and cable before use. Do NOT use the damaged SpO2 sensor.

 When the temperature of SpO

2

sensor is abnormal, do not use it any more.

 Please do not allow the cable to be twisted or bended.

 Do NOT put the SpO

2

sensor and pressure cuff on the same limb, otherwise the NIBP

measuring will affect SpO

2

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.

 The SpO

2

sensor can not be immerged into water, liquor or cleanser completely, because

the sensor has no capability of waterproofness.

3.3.3 TEMP Transducer Connection

Connecting methods:

1. Attach the transducers to the patient firmly;

2. Connect the cable to TEMP probe connector in the front panel.

Note: When unplugging the probe, be sure to hold the head of the connector and pull it out.

3.3.4 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 .

3. Cut one end of the paper into triangle, and load the paper from the underside of the
rubber roller.

4. Turn the roller clockwise to get the paper rolled, and put the paper roll into the

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.

-13-

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 3.5 Loading and taking out printing paper

3.3.5 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. 3.6 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.

Figure 3.6 Battery Installation

Note:

 Do not insert battery terminal with its polarities reversed, or the monitor can not

be started.

Underside view

-14-

 Please take out the battery before transport or storage.

-15-

Chapter 4 Operations

4.1 Initial Monitoring Screen

If the ECG cable is disconnected from the monitor or leads off from the patient, the ECG waveform

will become a base line in main display area and “Lead off” will appear at the left side of prompt

info area (as shown in Figure 4.1).

Figure 4.1 ECG waveform screen

The LCD screen will display the information by different display views, short pressing “

” key to

shift screen display among 4 display views: ECG waveform screen (Reserved), SpO

2

plethysmogram screen, SpO

2

trend graph screen, HR trend graph screen (Reserved) 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 Default Display Screen Description

Title area:

  1ECG lead status and ECG waveform scale.

 “ECG”: indicate the current monitoring parameter is ECG.

 “36.8”: temperature numerical value

Main display area:

 When ECG leads is attached on the patient and connected to the monitor well, ECG

waveform will be displayed in the main display area.

Prompt Info:

 Status or event indication segment:

-16-

This segment will display the ECG leads status, probe status, alarm silence

counting-down timer, automatic NIBP measurement 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: XXX”: the counting-down timer of NIBP measurement is XXX seconds. This

prompt message appears only when the NIBP measuring mode is set as “AUTO X”.

“mute C-D: XXX”: the counting-down timer of alarm silence is XXX seconds. This prompt

message appears only when the alarm silence is enabled.

 Patient ID segment:

“03”: Patient ID number.

 Real time clock segment:

“11:30:25”: the current time.

4.1.2 Operation Instructions

 “ ” key: shift display mode.

 “

” key: start/cancel NIBP measurement.

 “

” key: set or activate the system alarm. In the monitoring screen, press “Alarm” to

set the alarm timer. There are four options of alarm silent time: 2 minutes, 5 minutes, 10

minutes and 20 minutes. The time shows up on the upper left corner of the screen. When

the alarm timer is activated, the system begins to count down. If alarm occurs during that

period, the system alarm will be actived automatically and the monitor will give alarm. If

there is no alarm during that period, when the set time has passed the system alarm will

be actived as well.

When the monitor alarms, press

key to suspend the alarm and set the alarm silence

time.

-17-

4.2 SpO2 Monitoring Screen

Short time press “ Display” key to shift the screen view to SpO2 monitoring screen, as shown in

Figure 4.2.

Figure 4.2 SpO

2

Monitoring Screen

4.2.1 Screen Description

Title area:

 “PI: 3‰”: the perfusion index is 3‰; it displays only when “Setup MenuSpO2PI

Display” is set as “ON”.

Note: PI display function is optional and it needs hardware support.

 “PLETH”: Mark of SpO

2

plethysmogramwhen “PLETH” displays in title area, the main

display area will be SpO

2

plethysmogram, and this display screen is the default screen.

 “36.8”: temperature numerical value

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 4.2).

If the SpO

2

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 4.3).

Figure 4.3 Probe Off

-18-

4.2.2 Operation Instructions

 “” key: freeze Plethysmogram on the screen.

 “

” 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: set or activate the system alarm.

4.3 Trend Graph Display

Short pressing “ Display” key to shift the screen view to trend graph display screen, as shown in

Figure 4.4.

Figure 4.4 Trend Graph

4.3.1 Screen Description

 “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.

 “SpO

2

”: indicate that the trend graph beside it is SpO2 trend. Let the cursor stay here and

press“” key to confirm, then press “” key or “” key again to select trend graph type:

“SpO

2

”: SpO2 trend graph

“HR” HR trend graph (Reserved)

Trend length

Trend graph

-19-

4.3.2 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.

“

” key: Press it to print the current displayed trend graph.

“

” key: start/cancel NIBP measurement

“

” key: set or activate the system alarm.

4.4 NIBP List Screen

Short pressing “ Display” key to shift the screen to NIBP List screen, as shown in Figure 4.5.

Figure 4.5 NIBP List

The first column is the date, the second column is NIBP measuring time, the third column is NIBP

-20-

value, and the fourth column is pulse rate (measured by NIBP module). “SYS/DIA/MAP” indicates

the value of “systolic pressure/diastolic pressure/mean arterial pressure”.

4.4.1 Operation Instructions

On NIBP List screen, if NIBP measurement is more than 6 groups, press “” key or “” key to

scroll up or down through all the measurement values. If NIBP measurement is not more than 6

groups, the keys “”or “” are not effective.



“

” key: press this key to shift to next display view.



“

” key: print NIBP list.



“

” key: start/cancel measuring NIBP.



“

” key: set or activate the system alarm.

4.5 Setup Menu Screen

At any display view screen, long time press “ Display” key to shift the screen to Setup Menu

screen, as shown in Figure 4.6. All the functional parameters of the system can be set through

Setup Menu.

Figure 4.6 Setup Menu Screen

There are 8 functional groups for setting parameters: “ECG TEMP, SpO

2

, NIBP, Nurse Call, System,

Patient Info, Date/Time and Default” on the Setup Menu Screen.

1. Press“

” key or “” key to shift cursor to corresponding functional group setting.

2. Pres “

” key to confirm and enter into corresponding functional parameter setup screen.

3. Pres “

” key under the setup menu will print ECG waveform.

4. Press “

” to exist from Setup Menu Screen.

 At Setup Menu Screen or its submenu screen, when pressing “ ” key, the default display

screen will be printed.

The following will cover each functional parameter’s setting up.

Note: If you disabled Hi and Lo limit alarm function of parameter monitoring, all the alarms

-21-

related to its parameter monitoring will be disabled as well.

4.5.1 ECG and Temperature Setup

Figure 4.7 ECG/TEMP Setup Screen

Note: ECG monitoring function is optional. All the displays or setup related to ECG are

reserved for future use.

Screen Description:

 “TEMP ”: temperature alarm switch; “” indicates temperature alarm is on; “ ”

indicates temperature alarm is off.

 “TEMP Hi/Lo”: high/low limit of temperature alarm;

 “Unit”: body temperature unit. Two options: “” or “”. Conversion relation: 1=

(X1.8) +32.

 “T probe”: the type of temperature probe “KRK”;

4.5.2 SpO2 Setup

Figure 4.8 SpO

2

Setup Screen

Screen Description:

 “SpO2 ”: SpO2 alarm switch; “” indicates SpO2 alarm is on; “ ” indicates SpO2 alarm

is off.

 “SpO

2

Hi”: high limit of SpO2 alarm; range: “1~100”.

-22-

 “SpO2 Lo”: low limit of SpO2 alarm; range: “0~99”.

 “PR



”: pulse rate alarm switch; “” indicates PR alarm is on; “ ” indicates PR alarm

is off.

 “PR Hi”: high limit of PR

alarm; range: “22~250”.

 “PR Lo”: low limit of SpO

2

alarm; range: “0~248”.

 “PI display”: “on” means PI display is enabled; “off” means PI display is disabled.

Operation Instructions

1. Press “” key or “” key to move cursor to select parameter.

2. Press “

” key to confirm and active this parameter setting.

3. Press “

” key or “” again to adjust or modify parameter value.

4. Press “

”key again to confirm and save the setting.

5. Press “

” key to return to upper level screen.

4.5.3 NIBP Setup

Figure 4.9A NIBP Setup Figure 4.9B Tourniquet Setup

NIBP Setup Screen Description:

 “SYS ”: systolic pressure alarm switch; “” indicates systolic pressure alarm is on;

“

” indicates systolic pressure alarm is off.

 “SYS Hi”: high limit of systolic pressure alarm; range: “32~250” mmHg.

 “SYS Lo”: low limit of systolic pressure alarm; range: “30~248” mmHg.

 “DIA



”: diastolic pressure alarm switch; “” indicates diastolic pressure alarm is on;

“

” indicates systolic pressure alarm is off.

 “DIA Hi”: high limit of diastolic pressure alarm; range: “22~230” mmHg.

 “DIA Lo”: low limit of diastolic pressure alarm; range: “20~228” mmHg.

 “MAP



”: mean arterial pressure alarm switch; “” indicates mean arterial pressure

alarm is on; “

” indicates mean arterial pressure alarm is off.

 “MAP Hi”: high limit of mean arterial pressure alarm; range: “28~242” mmHg.

 “MAP Lo”: low limit of mean arterial pressure alarm; range: “26~240” mmHg.

-23-

 “Mode”: NIBP measuring mode, “manual”, “AUTO 1”, “AUTO 2”, …“AUTO 240” and

“STAT” etc. options. “AUTO 1” means NIBP measurement takes once every one minute

automatically; “AUTO 60” means NIBP measurement takes once every 60 minutes

automatically; In AUTO mode, the counting-down timer is displayed in the “Prompt Info”

area, as shown in Figure 4.1.

 “unit”: unit of the blood pressure value;

“mmHg” or “kPa” can be selected. Conversion: 1kPa=7.5mmHg.

 “>>”: Page down icon. When cursor stays in the “unit” filed, press “” key to enter

Tourniquet Setup.

Tourniquet Setup Screen Description:

 “Pressure”: when you use Tourniquet function, you need to preset a cuff pressure for

hemostasia. The pressure is adjustable, and its adjusting limit is different for different

patient category:

for infants: preset range: 80~130 mmHg, default value: “110” mmHg;

for adults: preset range: 80~180mmHg, default value: “140” mmHg.

If the pressure drops down slowly under 10mmHg compared with the preset value due to
little air leakage in the pneumatic system when time passes by, the monitor will re-inflate
to maintain the cuff pressure close to the preset pressure value.

Note: the unit of cuff pressure is the same with the NIBP unit in NIBP Setup.

 “Duration”: After presetting the cuff pressure, you need to set the time period for

maintaining the preset pressure after inflation. “5, 6, 7…120” minutes adjustable. The

default value is “40” minutes.

If the set value is “xx” minutes, the monitor will count down from “xx” minutes
automatically when starting cuff inflation. When time is up, it will deflate automatically.

 “Alert T”: the alert time for reminding user that the operation of tourniquet is going to be

end after this time period. 1 to 60 minutes adjusting range with 1 minute step, the default

value is “5” minutes. If the set value is “xx” minutes, the monitor will produce alarm sound

until ending deflation when counting down time reaches to “xx” minutes. The alarm type is

high priority alarm. (For example: the duration is 40 minutes, the alert time is 5 minutes, the

alarm will ring for prompt when the duration counting down to 5 minutes. The Prompt Info

area starts to prompt: TOUR C-D 300 seconds. )

 “Start”: shift cursor to “Start” and press “

” key, “Start” becomes “Stop” and meanwhile

the blood cuff starts being inflated; Pressing “Stop” button can stop using this function.

After deflation, it will change to “Start” again.

-24-

4.5.4 Nurse Call

Figure 4.10 Nurse Call Setup Screen

Screen Description:

 “Output level”: two options “low” or “high” output levels are available.

When the calling system in hospital works in “Normal Open” mode, “low level” should be

selected.

When the calling system in hospital works in “Normal Close” mode, “high level” should be

selected

 “Source”: three kinds of alarm sources can trig the nurse call: high level alarm, medium level

alarm and low level alarm (multi-optional). If you don’t make choice, nurse call signal will not
be sent out.

 “Duration”: two options “pulse” or “continuous” output modes are available;

“continuous”: the continuous mode of output means the nurse call signal will keep until

the selected alarm source(s) disappear, i.e. the signal will last from starting alarm to

stopping alarm.

“pulse”: the output nurse call signal is pulse signal which lasts for 1 second. When several
alarms occur at the same time, only one pulse signal will be sent out.

Note:

Nurse Call function can not be regarded as main alarm notice method, please do not

entirely relay on it. You should combine parameter values with alarm level and

patient’s clinical behavior and symptom to determine patient’s status.

-25-

4.5.5 System Setup

Figure 4.11 System Setup Screen

Screen Description:

 “Vol”: set beeper volume, “0~7” level adjustable, the set “0” i.e. no sound. The Alarm silence

key “

” will be disabled and the alarm silence indicator will be on to indicate no sound

when the system volume is set as “0”.

 “key beep”: to turn on/off key beep;

 “LANG”: language selection. “ENG” for English.

 “priority”: priority of “PR” value or “HR” value display. The default set is “HR”.

 “backlite”: turn on/off backlight;

 “contrast”: adjust LCD display contrast, “0~31” level adjustable;

 “care mode”: “Demo” shows the demo waveforms and data. In the demo state, all the

signals and data are generated from the monitor for demonstration and testing purpose.
“Real” shows the real time waveform, i.e. normal monitoring status;

 BT SD: turn on/off the pulse beeping sound.

-26-

4.5.6 Patient Info

Figure 4.12 Patient Info Screen

Screen Description:



“ID”: change or set current patient’s ID number, 0~100 adjustable;



“category”: change or set the category of current patient; two options “adult” and

“pediatric”, the default is “adult”.

Note: If the patient ID is changed, all the history data will be cleared, that means SpO

2

trend

graph and NIBP list will become empty.

4.5.7 Date/Time

Figure 4.13 Data/Time Setup Screen

Screen Description:

 “yy 07 mm 09 dd 21”: date setting, “07-09-21” shows the date is September 21st , 2007.

 “hh 10 mm 15 ss 20”: time setting, “092021” shows the time is10:15:20.

4.5.8 Recover Default Settings

On Setup Menu screen, press “” button or “” button to shift cursor to “Default”, and then

press “

” button, all the setting parameters will be reset to factory default setting value.

-27-

4.6 Power Saving Mode

On the initial display screen, you can make the monitor stay in power saving mode for power
saving. Short time press power button to shift screen to “Power Saving Mode” display screen,
as shown in Figure 4.14.

Figure 4.14 Power Saving Mode

Press “” button or “” button to shift cursor to “yes” or “no” and press “” button to confirm.
If your selection is “yes”, all the numerical values displayed on digital LEDs display become
darker and the monitor stays in power saving mode.

Short time press power button again to shift screen to “Power Saving Mode” display screen for
exiting the sleeping mode.

-28-

Chapter 5 Alarm

5.1 Alarm Priority

High Priority:

TOUR C-DXXX seconds
PR Over limit

SpO

2

over limit
SYS over limit

DIA Over limit
MAP Over limit

NIBP error 1#
NIBP error 2#

NIBP error 3#
NIBP error 4#

NIBP error 5#
Air leak

Cuff error
NIBP over range

Over motion
Over pressure

NIBP timeout

Medium Priority:

Probe Off

5.2 Alarm modes

When an alarm occurs, the monitor responds with visual alarm indications (which are shown by

two ways: alarm indicator and alarm message description) and audible alarm indications.

Visual Alarm Indicators

The flashing rates for the three categories of alarms are shown in the table below.

Indicator Color

Alarm Category Flashing Rate

Red flashing

High priority alarm 2 Hz

Yellow flashing

Medium priority alarm 0.5 Hz

Yellow light

Low priority alarm Constant(on)(non-flashing)

Table 5.1

Refer to Chapter 11.1 Alarm Information for detailed alarm message descriptions.

-29-

Audible Alarm Indications

The audible alarm has different tone pitch and on-off beep patterns for each priority category.

These are summarized in the Table below.

Alarm Category Tone Pitch Beep Rate

High priority alarm ~500Hz 2 beeps per 7 sec.

Medium priority alarm ~700Hz 4 beeps per 9 sec.

Low priority alarm ~600Hz 20 beeps per 13 sec.

Normal ~300Hz continuous

Table 5.2

Note: Visual alarm indicators can not be suspended or removed. Audible alarms may be

decreased in volume or silenced as described in Chapter 4.

5.3 Alarm Silence

Press key to set or activate the system alarm. In the monitoring screen, press “Alarm” to set

the alarm timer. There are four options of alarm silent time: 2 minutes, 5 minutes, 10 minutes and

20 minutes. The time shows up on the upper left corner of the screen. When the alarm timer is

activated, the system begins to count down. If alarm occurs during that period, the system alarm

will be actived automatically and the monitor will give alarm. If there is no alarm during that period,

when the set time has passed the system alarm will be actived as well.

When the monitor alarms, press

key to suspend the alarm and set the alarm silence time.

The Alarm silence key “

” will be disabled and the alarm silence indicator will be on to indicate

no sound when the system volume is set as “0”.

 DO NOT silence the audible alarm or decrease its volume if patient safety

could be compromised.

5.4 Alarm Setting

In the Mode Selection screen, move the cursor to the “SETUP”, and press it to enter system setup
screen.

 Limits setup: Move the gray cursor to the High or Low limits of the alarm settings, and press

the “Alarm” key to turn ON or OFF the alarm for the setting. Yellow color shows ON status,

and gray color shows the OFF status.

Refer to Chapter 11.2 for detailed Default Alarming Values of All Parameters and Setup Range.

 Whenever the monitor is used, check the alarm limits to ensure that they

are appropriate for the patient being monitored.

5.5 Verify Adjustable Alarm Function

To verify adjustable alarm function, select “Demo” for the item of Mode in system parameter

-30-

settings menu and adjust alarm limits or change alarm setting, then pay a close attention to the
alarm. If the alarm is sent out according to your setting, it means the alarm function is effective.

-31-

Chapter 6 Technical Specifications

6.1 NIBP Monitoring

1. Measuring method: Oscillometric Technique

2. Pneumatic pressure measuring range: 0 mmHg~300mmHg

3. Accuracy of pressure measurement: ±3 mmHg

4. Cuff inflation time: <10 seconds (typical adult cuff)

5. Measurement time on the average: < 90 seconds

6. Air release time while the measurement is canceled: <2 seconds (typical adult cuff)

7. Initial cuff inflation pressure

Adult: <180 mmHg; Infant: <120 mmHg;

8. Overpressure protection limit

Adult: 300 mmHg; Infant: 240mmHg;

9. NIBP measurement range:

pressunit

Adult Infant

SYS mmHg 40~255 40~200

MAP mmHg 20~215 20~165
DIA mmHg 10~195 10~150

10. NIBP accuracy:

Maximum mean error: ±5 mmHg

Maximum Standard deviation: 8 mmHg

11. Measurement mode: Manual, Auto, STAT

6.2 SpO2 Monitoring

1. Transducer: dual-wavelength LED

Measurement wavelength: red: 660 nm, infrared: 905 nm.

Maximal optical output power: less than 2mW maximum average

2. SpO

2

measuring range: 35%~99%

3. Low perfusion capability: 0.4%~5%

4. SpO

2

measuring accuracy: ≤3% for SpO2 range from 70% to 100%

*NOTE: this accuracy value is the root-mean-square value as defined in ISO 9919.

5. Update rate:

8 beats moving average for both SpO

2

and pulse rate readings

6.3 Pulse Monitoring

1. Pulse rate measuring range: 30bpm~240bpm

2. Pulse rate measurement accuracy: ±2bpm or ±2%, whichever is greater.

-32-

6.4 TEMP Monitoring

1. TEMP measuring range: 25.0~45.0

2. TEMP measuring accuracy: ±0.2

3. TEMP responding time: ≤150s

6.5 Data Recording

1. Sensitivity selection tolerance: ±5%

2. Recording speed: 25mm/s

3. Recording speed accuracy: ±10%

4. Hysteresis: ≤0.5mm

5. Frequency response: Monitoring mode: 0.5~40Hz

6. Time constant: Monitoring mode: ≥0.3s

6.6 Other Technical Specifications

1. AC power supply voltage: 100~240VAC

2. AC power frequency: 50/60 Hz

3. Fuse specification: T3.15AL/250V 520mm.

4. Internal power supply: 12VDC (rechargeable)

5. Battery specification: 12V 2.3AH (sealed lead-acid battery)

6. LCD resolution: 240160pixel

6.7 Operating Environment

Working Environment

Ambient temperature range: 5°C ~ 40°C

Relative humidity: 30 ~ 80%

Atmospheric pressure: 70kPa ~106kPa

Transport and Storage Environment

Ambient temperature range: -20°C ~ 60°C

Relative humidity: 10 ~ 95%

Atmospheric pressure: 50.0kPa ~107.4kPa

6.8 Classification

Safety standard IEC 60601-1

The type of protection against electric shock Classequipment.

The degree of protection against electric

Type BF, CF applied parts

Electro-Magnetic Compatibility: Group I, Class A

-33-

6.9 Manufacturer’s Declaration

Table 1

Guidance and manufacturer’s declaration-electromagnetic emission-

for all EQUIPMENT AND SYSTEMS

Guidance and manufacturer’s declaration-electromagnetic emission

PC-900/Classic-90 Vital Signs Monitor is intended for use in the electromagnetic environment
specified below. The customer or the user of the equipment or system should assure that it is used

in such an environment.

Emissions test Compliance Electromagnetic environment-guidance

RF emissions

CISPR 11

Group 1

PC-900/Classic-90 Vital Signs Monitor uses RF energy

only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any

interference in nearby electronic equipment.

RF emissions

CISPR 11

Class A

Harmonic emissions
IEC61000-3-2

Class A

Voltage
fluctuations/flicker

emissions
IEC61000-3-3

Complies

PC-900/Classic-90 Vital Signs Monitor is suitable for

use in all establishments other than domestic and
those directly connected to the public low-voltage

power supply network that supplies buildings used for
domestic purposes.

-34-

Table 2

Guidance and manufacturer’s declaration-electromagnetic emission-

for all EQUIPMENT AND SYSTEMS

Guidance and manufacturer’s declaration-electromagnetic emission

PC-900/Classic-90 Vital Signs Monitor is intended for use in the electromagnetic environment
specified below. The customer or the user of the equipment or system should assure that it is used in

such an environment.

Immunity test IEC60601 test level Compliance level

Electromagnetic environment

-guidance

Electrostatic
discharge(ESD)

IEC61000-4-2

±6 kV contact
±8kV air

±6 kV contact
±8kV air

Floors should be wood,
concrete or ceramic tile. if

floors are covered with
synthetic material, the relative

humidity should be at least
30%

Electrical fast

transient/burst

IEC61000-4-4

±2kV for power

Supply lines
±1 kV for

input/output lines

±2kV for power

Supply lines
±1 kV for

input/output lines

Mains power quality should

that of a typical commercial or
hospital environment.

Surge

IEC 61000-4-5

±1kV line (s) to line(s)
±2kV line(s) to earth

±1kV differential
mode

±2kV common
mode

Mains power quality should
that of a typical commercial or

hospital environment.

Voltage dips, short

interruptions and
voltage variations on

power supply input
lines

IEC61000-4-11

Mains power quality should be

that of a typical commercial or
hospital environment. If the

user of the equipment or
system requires continued

operation during power mains
interruptions, it is

recommended that the
equipment or system be

powered from an
uninterruptible power supply or

a battery.

Power

frequency(50Hz/60Hz)
magnetic field

IEC61000-4-8

3A/m 3A/m

Power frequency magnetic

fields should be at levels
characteristic of a typical

location in a typical commercial
or hospital environment.

-35-

NOTE UT is the a.c. mains voltage prior to application of the test level.

Table 3

Guidance and manufacturer’s declaration – electromagnetic

immunity-for EQUIPMENT and SYSTEM that are not

LIFE-SUPPORTING

Guidance and manufacturer’s declaration – electromagnetic immunity

PC-900/Classic-90 Vital Signs Monitor is intended for use in the electromagnetic environment
specified below. The customer or the user of PC-900/Classic-90 Vital Signs Monitor should assure
that it is used in such an electromagnetic environment.

IMMUNITY test

IEC 60601 test

level

Compliance

level

Electromagnetic environment - guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

3V

3 V/m

Portable and mobile RF communications
equipment should be used no closer to any
part of PC-900/Classic-90 Vital Signs
Monitor, including cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.

Recommended separation distance

Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).

b

Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey ,

a

should be less than the

compliance level in each frequency range .

b

Interference may occur in the vicinity of
equipment marked with the following
symbol.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected

-36-

by absorption and reflection from structures, objects and people.
a: Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, and electromagnetic site survey should be considered. If the measured field
strength in the location in which PC-900/Classic-90 Vital Signs Monitor is used exceeds the
applicable RF compliance level above, PC-900/Classic-90 Vital Signs Monitor should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating PC-900/Classic-90 Vital Signs Monitor.
b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Table 4

Recommended separation distances between portable and mobile

RF communications equipment and The equipment or

system-

for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING

Recommended separation distances between

portable and mobile RF communications equipment and The equipment or system

PC-900/Classic-90 Vital Signs Monitor is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of the equipment or

system can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the equipment or system as

recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter

m

Rated maximum

output power of

transmitter

W

150kHz to 80MHz

80MHz to 800MHz

80MHz to 2,5GHz

0,01 0.12 0.12 0.23

0,1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

-37-

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be determined using the equation applicable to the frequency of the

transmitter, where p is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.

NOTE 1 : At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.

NOTE 2 : These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

Chapter 7 Packaging and Accessories

7.1 Packaging

The product is packed in high quality corrugated cartons with foam inside to protect the equipment

against damage in the shipping and handling process.

Weight: Details see the indication on the outer package.

Dimension: 360(L)×320(W)×410(H) (mm)

7.2 Accessories

(1) NIBP cuff One piece

(2) SpO

2

probe One piece

(3) Temperature probe One piece

(4) Power cord One piece

(5) Grounding wire One piece

(6) User manual One copy

(7) Quality Certificate One copy

(8) Warranty Two copies

(9) Packing list Two copies

Note: The accessories are subject to change. Detailed items and quantity see the

Packing List.

-38-

-39-

Chapter 8 Working Principle

8.1 NIBP Monitoring

8.1.1 Measuring Principle

Blood pressure may be measured in an invasive way (whereby the sensor will be inserted into

blood vessel directly) or a non-invasive way. The non-invasive way includes several

methodologies, such as the Korotkoff Sound Method and oscillating method. The Korotkoff Sound

Method is used as a conventional way, whereby stethoscope is used to measure the blood

pressure. By the oscillating method, an inflation pump will fill the air, and release it slowly. A

computer will record change of the cuff pressure when the air is released. With this record, the

blood pressure value will be determined. First of all, make sure the signal quality judgment by

computer meets the requirements of accurate calculation (such as sudden limb movement or cuff

being hit during the measurement). If the answer is negative, give up the calculation. If the answer

is positive, proceed with calculation of the blood pressure value.

As change of the blood pressure is recorded by electric sensor, which sensitivity is much higher

than that of human ears, the oscillating method uses different definitions for measurement of

diastolic pressure, mean arterial pressure and systolic pressure from the Korotkoff Sound Method.

When the oscillating method is used, the circuit in the measuring apparatus will separate the

amplitude of the cuff pressure from its change with pulsation. With the oscillating method, the

blood pressure at the maximum amplitude of cuff pressure is defined as the mean arterial

pressure. The blood pressure at amplitude of cuff pressure forward reduced according to proper

proportion is defined as systolic pressure, while the blood pressure at amplitude of cuff pressure

backward reduced according to proper proportion is defined as diastolic pressure. The maximum

change of pulse pressure occurs at these two points. They are equivalent to the point with pulse

sound and the point without pulse sound respectively in the Korotkoff Sound Method.

When the risk of invasive monitoring method outweighs its advantage of accuracy, non-invasive

monitoring method shall be used.

Comparison between blood pressure measuring methods

To overcome the effect of human hearing variation and air release speed on measurement

accuracy when the conventional Korotkoff Sound Method is used to take measure of blood

pressure, people have been dedicated to study of automatic measurement of blood pressure. By

now, automatic blood pressure measuring system based on the principle of oscillating method is

mature. In practice, however, various problems are encountered, such as why the measures taken

by the oscillating method is lower or higher than those taken by Korotkoff Sound Method? Why

the measures are inclined to decline? Why, in some cases, no result is obtained in spite of the

inflation actions? Why the measure values have big discreteness and even abnormal data in some

cases? Why the SpO

2

waveforms may disappear suddenly? ...and so on. The following

explanations are devised to give the answers.

-40-

The Oscillating method vs. the Korotkoff Sound Method

Blood pressure measurement by the oscillating method and Korotkoff Sound Method has good
correlation with the invasive measurement. Notwithstanding, any of the non-invasive blood

pressure measurements has its one-sidedness when it is compared to the invasive measurement.
The oscillating method has its advantages over the Korotkoff Sound Method in less error, higher

reliability and stability. Their differences may be reflected in the following aspects.

1.The measures by the Korotkoff Sound Method are liable to effect of human factors. For

example, different people may have different sound judging ability, or different reactivity
when listening to heart sound and reading mercury meter. The air release speed and

subjectivity may also affect the judgment. By the oscillating method, the computation is
accomplished by the computer, thus relieving the possibility of effect due to human factor.

2.With the Korotkoff Sound Method, the measure is taken on the basis of appearance and

disappearance of heart sound. The air release speed and heart rate may have direct effect on
the measurement accuracy. It also has the disadvantages of rapid air release and poor

accuracy. In the contrast, with the oscillating method, the determination is calculated on the
basis of cuff pressure oscillatory waveform envelope, and the air release speed and heart rate

has little effect on the measurement accuracy.

3.Statistics show that, when measuring the hypertension, the measure taken by the oscillating
method is likely to be lower than that taken by the Korotkoff Sound Method. When measuring

the hypotension, the measure taken by the oscillating method is likely to be higher than that
by the Korotkoff Sound Method. But, it doesn’t mean the advantages or disadvantages

between the oscillating method and the Korotkoff Sound Method. Comparison with the
results taken by more accurate method, let’s say comparison of the invasive pressure result

with the output value by the blood pressure measuring simulator, will show which method
has more accurate results. In addition, higher or lower value should be a statistical concept. It

is recommended those used to adopt the Korotkoff Sound Method use different physiological
calibration for values determined by the oscillating method.

4.The studies have shown that the Korotkoff Sound Method has the worst accuracy when it

comes to measurement of hypotension, while the oscillating method has worse accuracy
when it comes to measurement of controlled hypertension relief.

8.1.2 Factors affecting NIBP measuring

 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.

Prior to use of the cuff, empty the cuff until there is no residual air inside it to ensure

accurate measurement.

Make the cuff mark  in the position where artery pulsates obviously, the effect will be

best.

The lower part of cuff shall 2cm above the elbow joint.



Do not wrap the cuff on too thick clothes(especially for cotton-padded clothes and

-41-

sweater ) to take measurement;

 The testee shall lie in bed or sit in chair, make the cuff and heart at the same level, the

result will be most accurate, other postures may have inaccurate result;

 During measuring, do not move your arm or the cuff;

 The measuring interval shall longer than 2 minutes, in continuous measurement, too short

interval may cause arm extrusion, blood quantity increases, then cause blood pressure

increases.

 Keep the patient still and stop talking before and during measuring;

 The patient’s mood also can affect the measuring result, when exciting, the blood

pressure goes up.

 The measuring result also affected by time, lower in the morning and higher in the

evening;

8.1.3 Clinical Limitations

1. Serious angiospasm, vasoconstriction, or too weak pulse.

2. When extremely low or high heart rate or serious arrhythmia of the subject occurs.

Especially auricular fibrillation will lead to unreliable or impossible measurement.

3. Do not take the measurement when the subject is connected with an artificial heart-lung
machine.

4. Do not take the measurement when the subject uses diuresis or vasodilator.

5. When the subject is suffering from major hemorrhage, hypovolemic shock and other
conditions with rapid blood pressure change or when the subject has too low body

temperature, the reading will not be reliable, for reduced peripheral blood flow will lead to
reduced arterial pulsation.

6. Subject with hyperadiposis;

In addition, statistics show that 37% people report blood pressure difference of no less
than 0.80kPa(6mmHg) between the left and right arms, and 13% people report difference of no

less than 1.47kPa (11mmHg).

Note: Some practitioners may report big discreteness or abnormal value of the

blood pressure measures when the oscillating method is used. As a matter of fact, the
so-called “big discreteness” must be a term in the sense of statistical significance of
mass data. Abnormal data may be observed in some individual cases. It is normal in the
scientific experiments. It may be caused by an apparent reason, or by an unknown factor
in some cases. Such individual doubtful experimental data may be identified and
eliminated using the special statistical technique. It is not a part of this manual. The
practitioner may eliminate the apparently unreasonable data according to the
experience.

-42-

8.2 SpO2 Monitoring

8.2.1 Measuring Principle

Based on Lamber-Beer law, the light absorbance of a given substance is directly proportional with
its density or concentration. When the light with certain wavelength emits on human tissue, the

measured intensity of light after absorption, reflecting and attenuation in tissue can reflect the
structure character of the tissue by which the light passes. Due to that oxygenated hemoglobin

(HbO

2

) and deoxygenated hemoglobin (Hb) have different absorption character in the spectrum

range from red to infrared light (600nm~1000nm wavelength), by using these characteristics, SpO

2

can be determined. SpO

2

measured by this monitor is the functional oxygen saturation -- a
percentage of the hemoglobin that can transport oxygen. In contrast, hemoximeters report fractional

oxygen saturation – a percentage of all measured hemoglobin, including dysfunctional hemoglobin,
such as carboxyhemoglobin or metahemoglobin.

8.2.2 SpO2 Measurement Restrictions (interference reason)

 Intravascular dyes such as indocyanine green or methylene blue

 Exposure to excessive illumination, such as surgical lamps, bilirubin lamps, fluorescent

lights, infrared heating lamps, or direct sunlight.

 Vascular dyes or external used color-up product such as nail enamel or color skin care

 Excessive patient movement

 Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or

intravascular line

 Exposure to the chamber with high pressure oxygen

 There is an arterial occlusion proximal to the sensor

 Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature

decreasing

8.2.3 Low SpO2 measuring value caused by pathology reason

 Hypoxemia disease, functional lack of HbO2

 Pigmentation or abnormal oxyhemoglobin level

 Abnormal oxyhemoglobin variation

 Methemoglobin disease

 Sulfhemoglobinemia or arterial occlusion exists near sensor

 Obvious venous pulsations



Peripheral arterial pulsation becomes weak



Peripheral blood supply is not enough

-43-

8.2.4 Clinical Limitations

 As the measure is taken on the basis of arteriole pulse, substantial pulsating blood

stream of subject is required. For a subject with weak pulse due to shock, low

ambient/body temperature, major bleeding, or use of vascular contracting drug, the SpO

2

waveform (PLETH) will decrease. In this case, the measurement will be more sensitive to

interference.

 For those with a substantial amount of staining dilution drug (such as methylene blue,

indigo green and acid indigo blue), or carbon monoxide hemoglobin (COHb), or

methionine (Me+Hb) or thiosalicylic hemoglobin, and some with icterus problem, the
SpO

2

determination by this monitor may be inaccurate.

 The drugs such as dopamine, procaine, prilocaine, lidocaine and butacaine may also be

a major factor blamed for serious error of SpO

2

measurements.

 As the SpO

2

value serves as a reference value for judgment of anemic anoxia and toxic

anoxia, the measurement result of some patients with serious anemia may also present
as good SpO

2

value.

8.2.5 Points to be noted in SpO2 and Pulse Measuring

 The finger should be properly placed (see the attached illustration of this instruction

manual), or else it may cause inaccurate measurement result.

 Make sure that capillary arterial vessel beneath the finger is penetrated through by red

and infrared lights.

 The SpO

2

sensor should not be used at a location or limb tied with arterial or blood

pressure cuff or receiving intravenous injection.

 Do not fix the SpO

2

sensor with adhesive tape, or else it may result in venous pulsation

and consequential inaccurate measurement result of SpO

2

.

 Make sure the optical path is free from any optical obstacles like adhesive tape.

 Excessive ambient light may affect the measuring result. It includes fluorescent lamp,

dual ruby light, infrared heater, and direct sunlight etc.

 Strenuous action of the subject or extreme electrosurgical interference may also affect

the accuracy.

 Please do not use the SpO

2

sensor when having the MRI, or burn may be caused by

faradism.

 Always observe the plethysmogram (waveform), which is auto-scaled within the range of

100. The SpO

2

reading may be unlikely true when the waveform is not smooth or irregular.

If in doubt, rely on your clinical judgment, rather than the monitor readout.

 A functional tester can not be used to assess the accuracy of the pulse oximeter monitor

or a SpO

2

sensor. However, a functional tester, such as SpO2 simulator can be used to
check how accurately a particular pulse oximeter is reproducing the given calibration

curve. Before testing the oximeter by a functional tester, please firstly ask the

-44-

manufacturer which calibration curve is used, if necessary, request the manufacturer for
its dedicated calibration curve and download it into the tester.

-45-

Chapter 9 Troubleshooting

9.1 No Display on the Screen

Shut down the machine and unplug the power. Use a universal meter to check if the outlet has

proper voltage, if the power cable is in good condition, and if the power cable is properly

connected with this apparatus or outlet. Remove the fuse from the back cover of this machine, and

make sure it is in good condition.

9.2 No Blood Pressure and Pulse Oxygen Measures

1. Check if the blood pressure cuff is properly wrapped around the arm according to the

operating instructions, if the cuff leaks, and if the inlet is closely connected with the NIBP

jack on the side panel. Check if the indicator of the pulse oxygen probe flashes and if the

pulse oxygen probe is properly connected to the SpO

2

jack on the side panel.

2. If the problems still exist, please contact the local dealer.

9.3 Blank Printing Paper

1. Check whether the printing paper is installed with its face reversed. Please reinstall it and

let the sensitive page face upward.

2. If the problems still exist, please contact the local dealer.

9.4 System Alarm

1. When the parameter value is higher or lower than the alarm limits, the alarm will ring.

Please check whether the alarm limit value is proper or the condition of the patient.

2. Probe off. Please check the connection of the probes.

Note: In case of trouble of this machine in the service, follow the instructions below to

eliminate the problem first. If the attempt fails, contact the dealer in your local area or the

manufacturer. Do not open the cabinet without permission.

-46-

Chapter 10 Maintenance

10.1 Service and Examination

10.1.1 Daily Examination

Before using the monitor, the checks below should be carried out:

 Check the monitor for any mechanical damage;

 Inspect the exposed parts and the inserted parts of all the leads, and the accessories;

 Examine all the functions of the monitor that are likely to be used for patient monitoring,

and ensure that it is in good working condition;

 Make sure that the monitor is grounded properly.

 Pay close attention to the fluctuation of the local power supply voltage. A manostat is

recommended when necessary.

 In case any indication of damage about the function of the monitor is detected and

proven, it is not allowed to apply it to the patient for any monitoring.

10.1.2 Routine Maintenance

After each maintenance or the yearly maintenance, the monitor can be thoroughly inspected by

qualified personnel, including function and safety examinations. The designed life of this monitor is

5 years. In order to ensure its long service life, please pay attention to the maintenance.

 If the hospital fails to carry out a satisfactory maintenance program about the

monitor, it may get disabled and harm the patient’s safety and health.

 In case of ECG leads damage or aging, please replace the lead.

 If there is any indication of cable and transducer damage or they deteriorate, they are

prohibited from any further use.

 The adjustable units in the monitor such as potentiometer are not allowed to adjust

without permission to avoid unnecessary failures that affect normal application.

10.1.3 Battery Maintenance

 Please pay attention to the polarity of battery, do NOT insert it into battery

compartment with reversed polarities;

 Do NOT use the batteries manufactured by other companies, if being inserted, the

device will may be damaged;

 In order to avoid damaging the battery, do NOT use other power supply device to

charge the battery;

-47-

 After battery ageing phenomenon occurring, to avoid explosion risk do NOT throw

the battery into fire.

 Do not hit or strike it with force;

 Do not use this battery on other devices;

 Do not use this battery below -10 or above 40;

 Dispose of the battery, the local law should be followed.



It is recommended to use the battery once a month to ensure its strong power

supply capacity and long service life, and recharge it after running out of the power.



In order to maintain battery supply time and prolong battery lifetime, please use the

battery once a month and do not charge it until it is used up each time.

Note: 1. when battery is used to supply power, user should not charge the battery until the low

battery alarm rings. (After line-haul or long-time storing, using battery may not start

the monitor, please charge the battery.)

2. The battery should be charged for 10 to 15 hours.

10.1.4 Service

If the monitor has functional malfunction or is not working, please contact the local dealer or our

company, and we are to offer the best solution as soon as possible for your satisfaction. Only

qualified service engineer specified by the manufacture can perform the service. Users are not

permitted to repair it by themselves.

10.2 Cleaning, Sterilization and Disinfection

 Kept the monitor from dust.



It is recommended to clean the outer shell and screen of the monitor to keep it clean. Only

non-corrosive cleanser such as clear water is permitted.

 Use the cloth with alcohol to wipe the surface of the monitor and transducers, and dry it

with dry and clean cloth or simply air-dry.

 The monitor can be sterilized and disinfected, please clean it first.

 Switch off the monitor and disconnect the power cable before cleaning.

 Do not let the liquid cleanser flow into the connector jack of the monitor to avoid

damage.

 Clean the exterior of the connector only.



Dilute the cleanser.



Do not let any liquid flow into the shell or any parts of the monitor.



Do not let the cleanser and disinfectant stay on its surface.



Do not perform high pressure sterilization to the monitor.

-48-



Do not put any parts of the monitor or its accessories in the liquid.



If the monitor is accidentally wetted it should be thoroughly dried before use. The

rear cover can be removed by qualified service technician to verify absence of

water.



Do not pour the disinfector on its surface while sterilization.

10.3 Cleaning, Sterilization and Disinfection of Accessories

It is recommended to use a cloth dampened with isopropyl alcohol 70%, a 10% aqueous solution

of sodium hypochlorite (bleach), a 2% gluteraldegyde solution, ammonia, mild soap or disinfectant

spray cleaner to clean the accessories (including sensor, ECG cable and plugs) before using.

 Do not use damaged accessories.

 Accessories can not be entirely immerged into water, liquor or cleanser.

 Do not use radial, steam or epoxyethane to disinfect accessories.

10.4 Storage

If the equipment will not be used for long period of time, wipe it clean and keep it in the packaging,

which shall be kept in a dry and good ventilation place free from dust and corrosive gases.

10.5 Transportation

This monitor should be transported by land (vehicle or railway) or air in accordance with the

contractual terms. Do not hit or drop it with force.

-49-

Chapter 11 Appendix

11.1 Prompt information explanations

Mute C-D: XXX seconds Alarm silence count down: XXX seconds

NIBP C-D: XXX seconds

NIBP auto measuring cycle count down: XXX seconds

TOUR C-D: XXX

Tourniquet alert count down: XXX seconds

Probe off SpO2 probe fells off

PR over limit PR value exceeds the high/low alarm limit

SpO2 over limit SpO2 value exceeds the high/low alarm limit

SYS over limit Systolic pressure value exceeds the high/low alarm limit

DIA over limit Diastolic pressure value exceeds the high/low alarm limit

MAP over limit MAP value exceeds the high/low alarm limit

NIBP error 1# Sensor or other hardware error

NIBP error 2#

Very weak signal because of the cuff, or the patient has very weak

NIBP error 3# Blood pressure amplifier overflow due to excessive movement

NIBP error 4# Leaking during the pneumatic device testing

Cuff error Cuff is not wrapped correctly, or is not connected

NIBP error 5#

Abnormal condition of CPU, such as register overflow, divided by

Air leak Air moving part, tube or the cuff leak air

NIBP over range The measurement range exceeds 255mmHg

Over motion

The repeated measurement due to moving, excessive noise during

the stepping inflation and measuring pressure and pulse, e.g. during

patient shaking motion

Over pressure

Cuff press exceeds the safety limit value of software. Limit value for

adult: 290mmHg; Limit value for pediatric: 145mmHg;
Or caused by cuff extrusion or flapping cuff with force.

NIBP timeout

Adult measurement is more than 120 seconds, infant measurement
is more

-50-

11.2 Default Alarming Values and Setup Range

Default

Mode

Parameter

Alarm range

Adult Pediatric

High

32~250

180mmHg 130mmHg

SYS

Low

30~248

60mmHg 50mmHg

High

22~232

120mmHg 90mmHg

DIA

Low

20~230

50mmHg 40mmHg

High

28~242

160mmHg 110mmHg

MAP

Low

26~240

50mmHg 40mmHg

High 1%~100% 100% 100%

SpO2

Low 0%~99% 90% 85%

High (22~250) bpm 180bpm 200bpm

Pulse rate

Low (20~248) bpm 40bpm 50bpm

High

24.1~46.0

39.0 39.0

TEMP

Low

24.0~45.9

34.0 34.0

11.3 Accessories List

Part No. Part Name Remark

15044034 Adult SpO2 Finger clip Sensor

15044038 Adult SpO2 Finger rubber Sensor

15044041 Pediatric SpO2 Finger clip Sensor

15024402 Adult NIBP cuff(25~35cm)

15021402 Small-sized Pediatric NIBP Cuff (6cm~11cm)

15022402 Middle-sized Pediatric NIBP Cuff (10cm~19cm)

15023402 Large-sized Pediatric NIBP Cuff(18cm~26cm)

5101-5236310 Thermal printer paper

2903-0000000 Power cord

2911-0003032 Grounding wire

900093 Net wire

For more information regarding the accessories, please contact your local sales

representative or the manufacturer.

-51-

11.4 Instructions for SpO2 Probe

Instructions for Pediatric SpO2 Finger Clip Sensor

Intended Use

When used with a compatible patient monitor or a pulse oximeter device, the sensor is intended
to be used for continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse
rate monitoring for pediatric patients weighing between 10~40kg.

Contraindications

This sensor is contraindicated for use on active patients or for prolonged use.

Instructions for Use

1) With the upper and lower jaws open, place an index finger evenly on the base of the clip.
Push the finger tip against the stop so that it is over the sensor window (A). If an index
finger cannot be positioned correctly, or is not available, other fingers can be used.

2) Note: When selecting a sensor site, priority should be given to an extremity free of an

arterial catheter, blood pressure cuff, or intravascular infusion line.

3) Spread open the rear tabs of the sensor to provide even force over the length of the pads

(B).

4) The sensor should be oriented in such a way that the cable is positioned along the top of

the hand (C).

5) Plug the sensor into the

oximeter and verify
proper operation as
described in the
oximeter operator’s
manual.

6) Inspect the monitoring site every 4 hours for skin integrity.

7) Before each use, surface-clean sensor and cable with a soft gauze pad by saturating it with

a solution such as 70% isopropyl alcohol. If low-level disinfection is required, use a 1:10
bleach solution.

Caution: Do not sterilize by irradiation steam, or ethylene oxide.

Warnings

1) Some factors may affect the accuracy of saturation measurements. Such factors include:
excessive patient motion, fingernail polish, use of intravascular dyes, excessive light, poor
blood perfusion in the finger, extreme finger sizes or improper placement of the sensor.

2) Using the sensor in the presence of bright lights may result in inaccurate measurements.

In such cases, cover the sensor site with an opaque material.

3) The sensor must be moved to a new site at least every 4 hours. Because individual skin

condition affects the ability of the skin to tolerate sensor placement, it may be necessary to
change the sensor site more frequently with some patients. If skin integrity changes,
move the sensor to another site.

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4) Do not apply tape to secure the sensor in place or to tape it shut; venous pulsation may
lead to inaccurate saturation measurements.

5) Do not immerse sensor as it causes short.

6) Do not use NIBP or other constructing instruments on same appendage as sensor for

blood flow interrupted by NIBP cuff or circulatory patient condition will result in no pulse
found or loss of pulse.

7) Do not use the sensor or other oximetry sensors during MRI scanning.

8) Carefully route cables to reduce the possibility of patient entanglement or strangulation.

9) Do not alter or modify the sensor. Alterations or modifications may affect performance or

accuracy.

10) Do not use the sensor if the sensor or the sensor cable appears damaged.

Instructions for Adult SpO2 Finger Rubber Sensor

Intended Use

When used with a compatible patient monitor or a pulse oximeter device, this SpO2 sensor is
intended to be used for continuous, non-invasive functional arterial oxygen saturation (SpO

2

)

and pulse rate monitoring for patients weighing greater than 50kg.

Contraindications

This sensor is contraindicated for use on active patients or for prolonged use.

Instructions for Use

1) Hold the sensor with its opening towards the patient’s index finger (A). The sensor should
be oriented in such a way that the sensor side with a finger tip sign is positioned on the top.

2) Insert the patient’s index finger into the sensor until the fingernail tip rests against the stop

at the end of the sensor. Adjust the finger to be placed evenly on the middle base of the
sensor. Direct the cable along the top of the patient’s hand. Apply adhesive tape to
secure the cable (B). If an index finger cannot be positioned correctly, or is not available,
other fingers can be
used.

3) Plug the sensor into

the oximeter and
verify proper
operation as
described in the
oximeter operator’s
manual.

4) Inspect the monitoring site every 4 hours for skin integrity.

Cleaning & Disinfection

Unplug the sensor before cleaning or disinfecting. Surface-clean sensor and cable with a soft
gauze pad by saturating it with a solution such as 70% isopropyl alcohol. If low-level
disinfection is required, use a 1:10 bleach solution.

-53-

Caution: Do not sterilize by irradiation steam, or ethylene oxide.

Warnings

1) This sensor is for use only with compatible patient monitors or pulse oximeter devices.
Use of this sensor with instruments other than compatibles may result in improper
performance.

2) Some factors may affect the accuracy of saturation measurements. Such factors include:

excessive patient motion, fingernail polish, use of intravascular dyes, excessive light,
poorly perfused finger, extreme finger sizes or improper placement of the sensor.

3) The sensor site must be checked for skin integrity at least every 4 hours. Because

individual skin condition affects the ability of the skin to tolerate sensor placement, it may
be necessary to change the sensor to another finger.

4) Do not use NIBP or other constructing instruments on same appendage as sensor for

blood flow interrupted by NIBP cuff or circulatory patient condition will result in no pulse
found or loss of pulse. Do not use the sensor during MRI scanning.

5) Carefully route cables to reduce the possibility of patient entanglement or strangulation.

6) Do not alter or modify the sensor. Alterations or modifications may affect performance or

accuracy.

7) Do not use the sensor if the sensor or the sensor cable appears damaged.

Instructions for Adult SpO2 Finger Clip Sensor

Intended Use

When used with a compatible patient monitor or a pulse oximeter device, the sensor is intended
to be used for continuous, non-invasive functional arterial oxygen saturation (SpO

2

) and pulse

rate monitoring for patients weighing greater than 40kg.

Contraindications

This sensor is contraindicated for use on active patients or for prolonged use.

Instructions for Use

1) With the upper and lower jaws open, place an index finger evenly on the base of the clip.
Push the finger tip against the stop so that it is over the sensor window (A). If an index
finger cannot be positioned correctly, or is not available, other fingers can be used.

2) Note: When selecting a sensor site, priority should be given to an extremity free of an

arterial catheter, blood pressure cuff, or intravascular infusion line.

3) Spread open the rear tabs of the sensor to provide even force over the length of the pads

(B).

4)

The sensor should
be oriented in such
a way that the cable
is positioned along

-54-

the top of the hand (C).

5) Plug the sensor into the oximeter and verify proper operation as described in the oximeter
operator’s manual.

6) Inspect the monitoring site every 4 hours for skin integrity.

7) Before each use, surface-clean sensor and cable with a soft gauze pad by saturating it with

a solution such as 70% isopropyl alcohol. If low-level disinfection is required, use a 1:10
bleach solution.

Caution: Do not sterilize by irradiation steam, or ethylene oxide.

Warnings

1) Some factors may affect the accuracy of saturation measurements. Such factors include:
excessive patient motion, fingernail polish, use of intravascular dyes, excessive light,
poorly perfused finger, extreme finger sizes or improper placement of the sensor.

2) Using the sensor in the presence of bright lights may result in inaccurate measurements.

In such cases, cover the sensor site with an opaque material.

3) The sensor must be moved to a new site at least every 4 hours. Because individual skin

condition affects the ability of the skin to tolerate sensor placement, it may be necessary to
change the sensor site more frequently with some patients. If skin integrity changes,
move the sensor to another site.

4) Do not apply tape to secure the sensor in place or to tape it shut; venous pulsation may

lead to inaccurate saturation measurements.

5) Do not immerse sensor as it causes short.

6) Do not use NIBP or other constructing instruments on same appendage as sensor for

blood flow interrupted by NIBP cuff or circulatory patient condition will result in no pulse
found or loss of pulse.

7) Do not use the sensor or other oximetry sensors during MRI scanning.

8) Carefully route cables to reduce the possibility of patient entanglement or strangulation.

9) Do not alter or modify the sensor. Alterations or modifications may affect performance or

accuracy.

10) Do not use the sensor if the sensor or the sensor cable appears damaged.

Creative offers a 6-momth warranty against manufacturing defects for the

-55-

Disposal: The product must not be disposed of along with other dome­stic waste. The users must dispose of this equipment by bringing it to a
specific recycling point for electric and electronic equipment. For further
information on recycling points contact the local authorities, the local
recycling center or the shop where the product was purchased. If the
equipment is not disposed of correctly, fines or penalties may be applie­d in accordance with the national legislation and regulations.

GIMA WARRANTY CONDITIONS

Congratulations for purchasing a GIMA product. This product meets high qualitative standards
both as regards the material and the production. The warranty is valid for 12 months from the
date of supply of GIMA. During the period of validity of the warranty, GIMA will repair
and/or replace free of charge all the defected parts due to production reasons. Labor costs and
personnel traveling expenses and packaging not included. All components subject to wear are
not included in the warranty. The repair or replacement performed during the warranty period
shallnot extend the warranty. The warranty is void in the following cases: repairs performed by u­nauthorized personnel or with non-original spare parts, defects causedby negligence or incor­rect use. GIMA cannot be held responsible for malfunctioning on electronic devices or software
due to outside agents such as: voltage changes, electro-magnetic fields, radio interferences,
etc. The warranty is void if the above regulations are not observed and if theserial code (if availa­ble) has been removed, cancelled or changed. The defected products must be returned only to
the dealer the product was purchased from. Products sent to GIMA will be rejected.