Contec Pm-60a User manual

1

CONTEC

PM-60

PM-60 A

A

A Pulse

Pulse

Pulse Oximeter

Oximeter

Users

’

Manual

CONTEC

The document including some secret information, belongs to Contec medical

systems co.

LTD.,

in which any information is not allowed to be transmitted, copied

,or disclosed to any other companies except the recipient ones, even not for other

commercial purposes.

Catalogue

Catalogue ………………………………………………………………………………………… ...2

1

1Preface

Preface

Preface …………………………………………………………………………………………

…………………………………………………………………………………………

………………………………………………………………………………………… .3

.3

2

1 .1 Caution Proceeding ……………………………………………………………………… .3

1 .2 Manipulator Obligation ………………… ..........................................................................3

2

2 The

The

The Basics..................................................................................................................

Basics..................................................................................................................

Basics.................................................................................................................. .................3

.................3

2.1 Introduction..................................................................................................... ....................3

2.1.1 Intended Use ...................................................................................... ....................4

2.1.2 Contraindications ............................................................................... ....................4

2.1.3 Components ....................................................................................... ....................4

2.2 Features …………………………………………………………………………………… 4

3

3 M

M

M ain

ain

ain Technical

Technical

Technical Index

Index

Index ……………………………………………………………………

……………………………………………………………………

…………………………………………………………………… ...

...

... …

…

… ..4

..4

3.1 Performance Specifications ……………………………………………………………… ..4

3.2 Technical specifications …………………………………………………………… . …… 5

3.3 SPO2 ……………………………………………………………………………… ...........6

4

4Function

Function

Function Instructions

Instructions

Instructions …………………………………………………………………………

…………………………………………………………………………

………………………………………………………………………… 6

6

4.1 Main interface …………………………………………………………………………… ..6

4.1.1 Composing parts ………………………………………………………………… .7

4.1.2 Function Button ………………………………………………………………… ..8

4.2 New patient information interface ……………………………………………………… ...8

4.3 Data Review Interface ……………………………………………………………… . …… 9

4.3.1 Data Review Interface ………………………………………………………… ....9

4.3.2 TrendTable Interface …………………………………………………………… .10

4.3.3 TrendGrape Interface …………………………………………………………… 10

4.3.4 AlarmReview and WaveReview Interface ……………………………………… 11

4.4 Setup Interface ………………………………………………………………………… ..

1

4.4.1 Setup Interface ………………………………………………… . ……………… .

1

4.4.2 System Setup ………………………………………………………… .. ……… ..13

5

5 Maintenance

Maintenance

Maintenance and

and

and Cleaning

Cleaning

Cleaning …………………………………………………………………

…………………………………………………………………

………………………………………………………………… ..14

..14

5.1 Safety Checks ……………………………………………………………………… ... … .15

5.2 Cleaning ………………………………………………………………………………… .15

5.3 Disinfecting ……………………………………………………………………………… 16

5.4 Disposal ………………………………………………………………………………… .16

6

6 Appendix

Appendix

Appendix ……………………………………

……………………………………

…………………………………… ...

...

... …………………………

…………………………

………………………… ...

...

... …………………

…………………

………………… .17

.17

6.1 Alarm characters specification ………………………………………………………… ...17

6.2 Usual metrical range …………………………………………………………………… ..17

1

1 Preface

Preface

This manual contains the instructions necessary to operate the product safely and

3

in accordance with its function and intended use. Observance of this manual is a

prerequisite for proper product performance and correct operation and ensures patient

and operator safety.

This manual is based on the maximum configuration and therefore some contents

may not apply to your product. If you have any question, please contact us.

This manual is an integral part of the product. It should always be kept close to

the equipment so that it can be obtained conveniently when needed.

This specification includes all the functions and operation flow, some usual

questions and detailed answers offered.

Please read the specification carefully before using this product to smooth your

usage .

Thanks for using PM-60A Pulse Oximeter products and look forward to your

valuable suggestions and advice.

PM-60A Website: http://www.contecmed.com.cn

1.1

1.1 Caution

Caution

Before usage, please be aware of safety and validity stated below :

�

The system should be used under doctors

’

guide.

�

The reliability of the product depends on whether the operation and

maintenance are properly done.

␇

␇Warning: system errors may arise if non-proper accessories are replaced;

therefore, any maintenance men who haven ’ t been trained in our company or

normal maintenance organization should not maintain this system.

1.2

1.2 Manipulator

Manipulator

Manipulator Obligation

Obligation

Caution: please read the user manual carefully before usage.

O

O bligations

bligations

bligations of

of

of Contec

Contec

Contec Medical

Medical

Medical System

System

System Co.

Co.

Co. LTD.

LTD.

1．Our company will resolve any software and hardware problems of the

product in one year after your purchase with the precondition of proper usage of it .

2．Responsible for user s' train ing .

3．Responsible for free update and life maintenance of the software.

4．Responsible for free maintenance of hardware after your purchase.

5. Not responsible for damage caused by improper usage or non-fixed

accessories usage.

2

2 The

The

The Basics

Basics

2.1

2.1 Introduction

Introduction

2.1.1

2.1.1 Intended

Intended

Intended Use

Use

The pulse oximeter is intended for continuously monitoring, spot checking,

displaying, storing and printing oxygen saturation and pulse rate of single adult,

pediatric and neonatal patient in hospital, emergency treatment and patient transport

4

as well as in home care environment.

WARNING

This

This pulse

pulse

pulse oximeter

oximeter

oximeter is

is

is intended

intended

intended for

for

for use

use

use only

only

only by

by

by clinical

clinical

clinical professionals

professionals

professionals or

or

under

under their

their

their guidance.

guidance.

guidance. It

It

It must

must

must only

only

only be

be

be used

used

used by

by

by persons

persons

persons who

who

who have

have

have received

received

adequate

adequate training

training

training in

in

in its

its

its use.

use.

use. Anyone

Anyone

Anyone unauthorized

unauthorized

unauthorized or

or

or untrained

untrained

untrained must

must

must not

not

not perform

perform

any

any operation

operation

operation on

on

on it.

it.

2.1.2

2.1.2 Contraindications

Contraindications

None.

2.1.3

2.1.3 Components

Components

This pulse oximeter consists of a main unit and a SpO2 sensor.

2.2

2.2 Features:

Features:

Regular Check Mode and Continuous Monitoring Mode

Data Graph and Trend Table Review

Rich Analysis report

Perfect mount solution

Sync with PC based Sofrware (WinXP and WinVista)

3

3 M

M

M ain

ain

ain Technical

Technical

Technical I

I

I ndex

ndex

3.1

3.1 Performance

Performance

Performance Specifications

Specifications

Display: 3.5" Color TFT

Resolution: 320 x 240

Display Mode: Standard face, Waveform face, Display Direction

adjustable

Indicator: Power indicator light, Alarm sound, Pluse tone

Interface: One dual-purpose socket for connecting SPO2

sensors and communication cables

Power Supply: DC 5V, <300MA

Battery: Builtin Li-Polymer, 6 hours for charging, 9 hours

for continous working.

1 2 hours for standby mode

3.7v,1900mah

Trend Graph /Table : Resolution from 1s, 5s, 10s ,30s,1min,and so on .

S torage of latest 96 hours trend data. Second is

the unit.

5

History : Storage of latest 10000 case history by SD card.

Permit to review momentarily.

Alarm: Ajustable High and Low limits. Three level audible

and vis u al alarm , latest 50 alarm information and

w aveform displays 8 seconds which 4 seconds are

before a certain time when the alarm is turned on

and 4 seconds are after appointed time when the

alarm is turned on.

Wave: Storage of 24 hours waveform, and only the real-

time stored patients have waveform.

3.2

3.2 Technical

Technical

Technical specifications

specifications

Safety

Meet the requirment of IEC60601 series

Type of Protection: Class II with internal electirc power supply

Degree of Protection: BF

Dimention and Weight

Dimention: 92(W)x82(H)x22(D)mm

Weight: 136g(with battery)

Operation Environment:

Temperature: 0 ℃ ~ +40 ℃

Humidity: 15% ~ 95%

Storage Environment:

Temperature: -20 ℃ ~ +60 ℃

Humidity: 10% ~ 95%

Patient Range

Neonate ,Pediatric and Adult

3.3

3.3 SPO2

SPO2

Measurement Range: 0 ~ 100%

Resolution: 1%

6

Accuracy: ± 2%(70%~100%, Adult/Pediatric, non-motion)

± 3%(70%~100%, Neonate, non-motion)

0% ~ 69% unspecified

Alarm Range: 0% ~ 100%

Refreshing Rate: 1s

Pulse

Pulse Rate:

Rate:

Measurement Range: 25 ~ 250 bpm

Resolution: 1bpm

Accuracy: ± 3 bpm (non-motion)

Alarm Range: 25 ~ 250 bmp

Refreshing Rate: 1s

4 Function Instructions

4.1

4.1 Main

Main

Main Interface

Interface

The system will enter automatically the main interface after first startup .

T

welve parts

make up of the main interface, as follows charts:

Model 4-1-1 main1 Mode1 4-1-2 main2

Notice

Notice :Between

:Between

:Between of

of

of the

the

the above

above

above figures,

figures,

figures, the

the

the Model

Model

Model 4-1-1

4-1-1

4-1-1 shows

shows

shows the

the

the layout

layout

layout of

of

of the

the

wave

wave screen

screen

screen and

and

and the

the

the Model

Model

Model 4-1-2

4-1-2

4-1-2 shows

shows

shows the

the

the layout

layout

layout of

of

of the

the

the normal

normal

normal screen.

screen.

4.1.1

4.1.1 Introduce

Introduce

Introduce the

the

the composing

composing

composing Parts

Parts

Parts as

as

as follows:

follows:

7

Model 4-1-3 Main

1. Patient ID Area:

This area shows the ID number of the patients monitoring currently.

2. Patient category Area:

This area shows the patient range.

Patients are classified as adult, pediatric and neonate.

3. System Time Area

4. Heart Rate Area:

Click the button can shield the sound of the heart murmur. The button and

the button flicker alternately after the sounds are turned off .

5. Battery symbol Area:

This area shows the electrical voltage of the battery.

6. Alarm Status Area:

indicates that alarm sounds are turned on;

indicates that alarm sounds are turned off.

7. SpO2 Area

8. PR Area

9. Physiological Alarm Area:

This area shows the physiological alarm message. When multiple messages come,

they will be displayed circularly.

10. Physiological Alarm Status Area:

Click the button to pause or reactivate the alarm sound.

8

indicates that alarm sounds are paused.

11. Waveform Area:

This area displays SPO2 real time waveform.

12. Function button Area

4.1.2

4.1.2 Function

Function

Function button:

button:

Functions as follows:

4.2

4.2 New

New

New Patient

Patient

Patient Information

Information

Information Interface

Interface

C lick the “ ” button of the main interface to enter the N ew patient case

history interface. New P atient information interface showed as followed:

M odel 4-2-1 New Patient

U sers

’

can set up and store the personal information of the patient monitoring

currently. After the patient information is stored, it will return to the main menu. The

“” button change into the " " button. T hen click the button can store the

E nter the new patient case history menu. P atient

’

s case history

should be set up and stored 10,000 at best .

E nter the data review menu. Review the monitoring data of

the current patient or the patients who had been stored

previously.

E nter the system setup menu.

A mend the system setup.

Press this button to make that alarm sounds are turned off.

The sounds of the heart murmur still are turned on.

Press this button to return to the main menu .

9

personal information of the patient monitoring currently into the SD card.

4.3

4.3 Data

Data

Data Review

Review

Review Interface

Interface

4.3.1

4.3.1 Data

Data

Data Review

Review

Review Interface

Interface

C lick the “ ” button of the main interface to enter the patient data review

interface. Data review interface showed as followed:

M odel 4-3-1 Data Review

U sers can review the monitoring data of the current patient

or

the patients who

had been stored previously by selecting "Patient ID".

R eview includes 4 kinds: "TrendTable", "TrendGraph", "AlarmReview" ,"WaveReview", as

followed:

N otice: the "Wave Review" function only be applicable for the patients

monitoring currently and not be applicable for the patients monitoring previously.

B y click S how Stat. I tem ,users can choose whether

or

not to show statistic in the TrendTable.

And the item is only applicable for TrendTable.

M enu : Functions listed in below chart:

4.3.2

TrendTable

TrendTable Interface

Interface

Patient ID

S elect the Patient ID that is needed to review

Review Type

S elect the category that is needed to review

Resolution

R eview Resolution only be applicable for "TrendTable"

and "TrendGraph" .

Start Time

S e t up the starting time of review

10

TrendTable

TrendTable Interface

Interface

Interface showed as followed:

M odel 4-3-2 TrendTable

The detailed information of the key as following:

4.3.3

TrendGraph

TrendGraph Interface

Interface

TrendGraph

TrendGraph Interface

Interface

Interface showed as followed:

M odel 4-3-3 TrendGraph

4.3.3. １.

Click one point on the screen to descry the parameter value of Spo2 and PR at

a

certain time.

4.3.3. ２. TrendGraph can analysis the data.

It

does some basis statistical analysis as well as SpO2 and pulse events analysis.

Max :

The maximum of the Parameter data in the logical range

Min:

The m in imum of the Parameter data in the logical range

Ave:

The average of the Parameter data in the logical range

11

SpO2 desaturation event is defined as drop in SpO2 by at least N% for

a

minimum

duration of L seconds. N and L are configurable, and is defaulted to 4 and 10.

Pulse event is defined as change in pulse rate by at least N bpm( beats per minute)

for

a

minimum duration of L seconds. N and L are configurable, and defaulted to 6 and

8.

You

can set the analysis parameters in the "System Setup" Menu.

4.3.4

4.3.4 AlarmReview

AlarmReview

AlarmReview and

and

and WaveReivew

WaveReivew

WaveReivew Interface

Interface

AlarmReview

AlarmReview and

and

and WaveReivew

WaveReivew

WaveReivew Interface

Interface

Interface showed as followed:

M odel 4-3-4 AlarmReview and WaveReivew

I n the AlarmReview waveform display district

,

w aveform displays 8 seconds

which 4 seconds are before

a

certain time when the alarm is turned on and 4 seconds

are after appointed time when the alarm is turned on.

T his alarm symbol includes following items:

“＊” : low- level alarm

“＊＊ ” : mid-level alarm

“＊＊＊ ” : high- level alarm

The waveform be displayed 1 6 seconds e very screen in the Wave Review

waveform display district .

4.4

4.4 Set

Set

Set up

up

up Interface

Interface

4.4.1

4.4.1 Set

Set

Set up

up

up Interface

Interface

C lick the “ ” button of the main interface to enter the Setup interface.

12

Setup interface showed as followed:

M odel 4-4-1 Setup

Instruction:

Monitoring

Monitoring setting

setting

setting and

and

and producer

producer

producer setting

setting

setting Options

Options

Options as

as

as follows

follows

follows :

:

NOTICE:

NOTICE: If

If

If the

the

the time

time

time is

is

is changed,

changed,

changed, users

users

users should

should

should restart

restart

restart the

the

the apparatus

apparatus

apparatus by

by

by hand

hand

hand to

to

ensure

ensure the

the

the accuracy

accuracy

accuracy of

of

of the

the

the data

data

data storage

storage

storage time.

time.

Item

Purpose

Producer

setting

Choosing scope

Spo2 ALM

T

urn on/off Spo2 alarm

OFF

OFF ON

Spo2 ALM

LVL

Spo2 alarm level

MID

LOW,

MID, HIGH

Spo2 ALM HI

Spo2 alarm high-level

99

0----100

Spo2 ALM LO

Spo2 alarm low-level

80

PR ALM

T

urn on/off PR alarm

OFF

OFF ON

PR ALM LVL

PR alarm level

MID

LOW,

MID, HIGH

PR ALM HI

PR alarm high-level

110

0-----300

PR ALM LO

PR alarm low-level

50

Alarm Pause

Alarm Pause Time

1MIN

1Min,2Min,3Min,Always

Display

D isplay mode

Mode1

Mode1, Mode2

System Time

S et system time

System Setup

E nter system setup menu

Pulse Sound

Turn on/off pulse sound

OFF ON

Demo

E nter Demo mode

13

4.4.2

4.4.2 System

System

System Setup

Setup

C lick the “ ” button of the Setup menu to enter the System Setup

menu interface. System Setup menu interface showed as followed:

M odel 4-4-2 System Setup

4.4.2.

4.4.2. １

１

１.

.

Users can set system sounds and overtime of the backdrop lighting .

4.4.2.

4.4.2. 2.

2.

2. SpO2 Parameters

󴖦Drop for Event (%): value, in %, to qualify as an SpO2 (Desaturation) Event.

󴖦Minimum Event Duration (sec): value, in seconds, of SpO2 decrease that qualifies

as an SpO2 (desaturation) event.

󴖦Desaturation Criteria Level (%): value, in %, below which the SpO2 level must

drop to be classified in

a

special category of statistics. This threshold is indicated on

the SpO2 graph by

a

red dotted line.

Pulse Rate Parameters

󴖦Rate Change For Event (bpm): value, in beats per minute, to qualify as

a

pulse rate

event.

󴖦Minimum Event Duration (sec): value, in seconds, of pulse rate change to qualify

as

a

pulse rate event.

14

4.

4. 4.2.

4.2.

4.2. 3.

3.

Click “ OK ” to set new analysis parameters

or

click “ Cancel ” to leave them

unchanged.

All setting will turn back to manufacture's setting when Click “ ” button .

5 Maintenance and Cleaning

Use only the substances approved by us and methods listed in this chapter to

clean

or

disinfect your equipment. Warranty does not cover damage caused by

unapproved substances

or

methods.

We

make no claims regarding the efficacy of the listed chemicals

or

methods as

a

means for controlling infection. For the method to control infection, consult your

hospital

’

s Infection Control Officer

or

Epidemiologist.

Keep you equipment and accessories free of dust and dirt.

To

avoid damage to the

equipment, follow these rules:

�

Always dilute according the manufacturer

’

s instructions

or

use lowest possible

concentration.

�

Do not immerse part of the equipment into liquid.

�

Do not pour liquid onto the equipment

or

accessories.

�

Do not allow liquid to enter the case.

�

Never use abrasive materials (such as steel wool

or

silver polish),

or

erosive

cleaners (such as acetone

or

acetone-based cleaners).

WARNING

�

Be

Be sure

sure

sure to

to

to shut

shut

shut down

down

down the

the

the system

system

system and

and

and disconnect

disconnect

disconnect all

all

all power

power

power cables

cables

cables from

from

from the

the

outlets

outlets before

before

before cleaning

cleaning

cleaning the

the

the equipment.

equipment.

CAUTION

�

If

If you

you

you spill

spill

spill liquid

liquid

liquid on

on

on the

the

the equipment

equipment

equipment or

or

or accessories,

accessories,

accessories, contact

contact

contact us

us

us or

or

or your

your

service

service personnel.

personnel.

NOTE:

�

To

clean

clean or

or

or disinfect

disinfect

disinfect reusable

reusable

reusable accessories,

accessories,

accessories, refer

refer

refer to

to

to the

the

the instructions

instructions

15

delivered

delivered with

with

with the

the

the accessories.

accessories.

5

5 .1

.1

.1 Safety

Safety

Safety Checks

Checks

Before every use,

or

after your pulse oximeter has been used for 6 to 12 months,

or

whenever your pulse oximeter is repaired

or

upgraded,

a

thorough inspection should

be performed by qualified service personnel to ensure the reliability.

Follow these guidelines when inspecting the equipment:

�Make sure that the environment and power supply meet the requirements.

�Inspect the equipment and its accessories for mechanical damage.

�Inspect all power cords for damage, and make sure that their insulation is in

good condition.

�Make sure that only specified accessories are applied.

�Inspect if the alarm system functions correctly.

�Make sure that the batteries meet the performance requirements.

�Make sure that the pulse oximeter is in good working condition.

In case of any damage

or

abnormity, do not use the pulse oximeter. Contact your

hospital

’

s biomedical engineers

or

your service personnel immediately.

5

5 .2

.2

.2 Cleaning

Cleaning

Your

equipment should be cleaned on

a

regular basis. If there is heavy pollution

or

lots of dust and sand in your place, the equipment should be cleaned more frequently .

Before cleaning the equipment, consult your hospital

’

s regulations for cleaning the

equipment.

Recommended cleaning agents are:

�Mild soap (diluted)

�Ammonia (diluted)

�Sodium hypochlorite bleach (diluted)

�Hydrogen peroxide (3%)

�Ethanol (70%)

16

�Isopropanol (70%)

To

clean your equipment, follow these rules:

1. Shut down the pulse oximeter and disconnect it from the power line.

2. Clean the display screen using

a

soft, clean cloth dampened with

a

glass cleaner.

3. Clean the exterior surface of the equipment using

a

soft cloth dampened with the

cleaner.

4. Wipe off all the cleaning solution with

a

dry cloth after cleaning if necessary.

5. Dry your equipment in

a

ventilated, cool place.

5

5 .3

.3

.3 Disinfecting

Disinfecting

Disinfection may cause damage to the equipment and is therefore not

recommended for this pulse oximeter unless otherwise indicated in your hospital

’

s

servicing schedule.

Clean the pulse oximeter before disinfecting it.

The recommended disinfectants include: ethanol 70%, isopropanol 70%,

glutaraldehyde-type 2% liquid disinfectants.

CAUTION

�

�Never

Never

Never use

use

use EtO

EtO

EtO or

or

or formaldehyde

formaldehyde

formaldehyde for

for

for disinfection.

disinfection.

5

5 .4

.4

.4 Disposal

Disposal

Dispose of the pulse oximeter in accordance with local environment and waste

disposal regulations. For the disposal of SpO2 sensor, follow local regulations

regarding disposal of hospital waste.

6. Appendix

6.1.

6.1. Alarm

Alarm

Alarm Characters

Characters

Characters Specification:

Specification:

Finger Out

SPO2 Sensor OFF

17

Battery

Too

Low

SPO2

Too

High

SPO2

Too

Low

PR

Too

High

PR

Too

Low

6.2.

6.2. Usual

Usual

Usual Metrical

Metrical

Metrical Range:

Range:

SPO2 1-99

PR 1-250

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