Shinova DM8D User manual

DM8D Defibrillator
User’s Manual
Shinova Systems Co., Ltd.
Preface
All the installation, expansion, readjustment, renovation or repairs are conducted
The electrical safety status at the installation site of the instrument conforms to
The instrument is used in accordance with the operation procedures.
Thank you for using defibrillator.
In order to enable you to skillfully operate defi-Monitor as soon as possible, we
provide this user’s manual with delivery. When you install and use this instrument for the
this instrument.
Based on the need to improve the performance and reliability of the parts and the
whole instrument, we sometimes will make some amendments to the instrument
(including the hardware and software). As a result, there might be cases of discrepancies
between the manual and the actual situation of products. When such discrepancies occur,
we will try our best to amend or add materials. Your comments and suggestions are
welcome.
Statement
This manual contains exclusive information protected by copyright laws and we
reserve its copyright. Without written approval of manufacturer no parts of this manual
shall be photocopied, Xeroxed or translated into other languages.
The contents and version contained in this manual are subject to amendments without
notification.
The version number of this manual: A2
Liabilities of the Manufacturer
Only under the following circumstances will manufacturer be responsible for the
safety, reliability and performance of the instrument.
by the personnel certified by manufacturer
the national standards;
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CONTENTS
1.1 INTENDED USE............................................................................................................. 1
1.2 ABOUT THIS MANUAL.................................................................................................1
1.3 BRIEF INTRODUCTION TO THE MONITOR.................................................................. 3
1.4 APPEARANCE AND STRUCTURE OF THE MONITOR.................................................... 4
2.1 GENERAL SAFETY....................................................................................................... 1
2.2 SOME IMPORTANT NOTES FOR SAFETY...................................................................... 3
2.3 CLASSIFICATIONS........................................................................................................5
2.4 SAFE OPERATING AND HANDLING CONDITIONS.......................................................5
3.1 OPEN THE PACKAGE AND CHECK............................................................................. 1
3.2 CONNECT POWER....................................................................................................... 1
3.3 CONNECT TO THE CENTRAL MONITOR SYSTEM....................................................... 4
3.4 POWER ON THE MONITOR.......................................................................................... 4
3.5 CONNECT PATIENT SENSORS..................................................................................... 4
4.1 MAIN MENU................................................................................................................ 1
4.2 WORK SCREEN............................................................................................................ 1
4.3 SETUP VOLUME............................................................................................................ 2
4.4 SETUP WAVE SWEEP SPEED.......................................................................................... 2
4.5 SETUP PATIENT INFORMATION................................................................................... 2
4.6 SYSTEM SETUP............................................................................................................. 3
4.7 SETUP RECORDER........................................................................................................ 5
4.8 RESTORE DEFAULT SYSTEM SETUP.............................................................................6
4.9 DISPLAY OF TREND......................................................................................................7
4.10 DISPLAY INFORMATION ON THE SCREEN.................................................................8
CHAPTER 1 GENERAL INTRODUCTION...................................................................1
CHAPTER 2 IMPORTANT SAFETY NOTES.................................................................1
CHAPTER 3 GETTING STARTED..................................................................................1
CHAPTER 4 OPERATION INSTRUCTIONS................................................................ 1
3
CHAPTER 5 PARAMETERS MEASUREMENT........................................................... 1
5.1 MEASUREMENT OF ECG/HR..................................................................................... 1
5.2 MEASUREMENT OF RESP...........................................................................................8
6.1 ALARM PRIORITY........................................................................................................1
6.2 ALARM MODES........................................................................................................... 1
6.3 ALARM SETUP..............................................................................................................2
6.4 ALARM STATE ICON.....................................................................................................3
6.5 SILENCE/ALARM PAUSED................................................................................... 4
6.6 PARAMETER ALARM................................................................................................... 4
6.7 WHEN AN ALARM OCCURS........................................................................................ 5
6.8 ALARM DESCRIPTION AND PROMPT..........................................................................5
8.1 SYSTEM CHECK......................................................................................................... 11
8.2 BATTERY MAINTENANCE.......................................................................................... 12
8.3 GENERAL CLEANING................................................................................................ 13
8.4 CLEANING AGENTS................................................................................................... 13
8.5 STERILIZATION..........................................................................................................14
8.6 DISINFECTION........................................................................................................... 14
A.1 ENVIRONMENTAL SPECIFICATIONS.........................................错误!未定义书签。
A.2 PHYSICAL SPECIFICATIONS..................................................... 错误!未定义书签。
A.3 HARDWARE SPECIFICATIONS.................................................. 错误!未定义书签。
A.4 PARAMETER SPECIFICATIONS................................................. 错误!未定义书签。
B.1 SYSTEM..................................................................................... 错误!未定义书签。
B.2 ECG.......................................................................................... 错误!未定义书签。
CHAPTER 6 ALARM.........................................................................................................1
CHAPTER 7 RECORDING...............................................................................................1
CHAPTER 8 THE MAINTENANCE AND CLEANING.............................................. 11
CHAPTER 9 ACCESSORIES AND ORDERING INFORMATION错误!未定义书签。
APPENDIX A TECHNICAL SPECIFICATIONS......................... 错误!未定义书签。
APPENDIX B DEFAULT SYSTEM SETUP..................................错误!未定义书签。
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B.3 RESP...................................................................................... 错误!未定义书签。
Defibrillation………… ……………………………………………………………… 16
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Defibrillator user’s manual

Chapter 1 General Introduction

1.1 Intended use

Defi-Monitor is used to monitor patient's physiological parameters such as ECG、RESP.
It is intended to be used in various hospital rooms such as Coronary Care UnitIntensive
Care Unit Neonatal Intensive Care Unit and Operating Room to provide additional
information to medical and nursing staff about the physiological condition of the patient.
It is not intended to be used in outdoor transport applications.

1.2 About this Manual

This user’s manual consists of the following chapters:
Chapter 1 gives an introduction to the content and the specific signs of this manual,
the main features and appearance of the monitor, the basic operations of various buttons,
the meanings of the signs on the monitor.
Chapter 2 gives important safety notes Please do read this chapter before using the
monitor!
Chapter 3 gives an introduction to the preparatory steps before using the monitor.
Chapter 4 provides general operation instruction for the monitor, including
illustrations of the screen display, normal selection for soft button on screen, details for
entry of patient data and trend maps, also.
Chapter 5 gives details of specific parameter measurement, preparatory steps, cables
or probes connection, setup of parameters, maintenance and cleaning of equipments and
sensors.
Chapter 6 gives detailed description of system alarm, including level and mode of
alarm, default setting and changing procedure of alarm parameters, prompt of specific
alarms, and the general operation to carry out when an alarm occurs.
Chapter 7 gives detailed description of record function.
Chapter 8 gives general maintenance and cleaning methods of the monitor and its
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Defibrillator user’s manual
parts.
Signs in this manual:
Warning: Indicates a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury.
Caution: Indicates a potential hazard or unsafe practice which, if not avoid, could result in minor personal injury or product/property damage.
Note: Provides application tips or other useful information to assure that you get the most from your equipment.
Note: This user manual introduced the product that with full configuration.
Some functions of the product you bought may be has not provided.
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1.3 Brief Introduction to the Monitor Part
Multiple measuring functions include 3-lead, 7-lead ECG/HR, RESP.
Complete built-in module design ensures stable and reliable performanceCan store the trend data for 72 hours and has the function of displaying trend data
Optional built-in recorder supports real-time recording, present screen printout and
Parameter display with big character
7” color high brightness TFT LCD monitor
Portable design, stylish and convenient
Rechargeable maintenance-free battery, can continue working when AC power is off
Nurse call function guarantee patient alarm draws enough attention
Can be connected with the central station to realize centralized monitoringIs resistant to high-frequency electrotome and is protected against defibrillation
The monitor has features as follows:
and trend maps
trigger printout by alarm
Defibrillator user’s manual
effects
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1.4 Appearance and Structure of the Monitor Parts
1. Energy selector: to select the energy of the heart defibrillating treatment
2. AC power indicator lamp
3. monitor Power switch
4. Battery charging indicator lamp
5. Press this key to open the menu dialog when there is no dialog on the
6. Press this key less than 2 seconds can make the monitor alarm paused or
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8
6
9 11
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1.4.1 The Front Appearance

Defibrillator user’s manual
It is turned on when AC power is connected. It is turned out when then AC power is not connected.
It is illumined when the battery is being charged. It is go out when the battery is fully charged or no battery in monitor.
screen, otherwise, pressing this key can close the dialog on the screen.
cancel the pause.
Pressing this key over 2 seconds can silence the monitor’s audio system or
cancel the silence.
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7. Trim Knob
The Trim Knob is used for:
8. Press this key to freeze or defreeze the wave display on screen.
9. Press this key to change the lead:Ⅰ、Ⅱ、Ⅲ、Avr、Avl、Avf、V.
10. Press this key to start or stop the real-time recording.
11. Defibrillator Power switch
1. ECG socket
1. AC input socket
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Turn left or turn right to move the cursor. Press down to perform an operation, such as open the menu dialog or selects one option.

1.4.2 The Left Side Appearance

Defibrillator user’s manual
Warning: The sensor cable sockets on the monitor can only be connected with the
sensor cables supplied with this instrument and no other cables shall be used.

1.4.3 The Back Appearance

Caution: The AC input at the back panel of the Monitor should be connected with the 100V~240V AC Power by electrical wires supplied with this instrument.
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Defibrillator user’s manual
2. Potential equalization conductor terminal
3. FUSE
Signs
Notes on the signs
Defibrillator-proof type CF equipment (Refer to IEC 60601-2-27)
The unit displaying this symbol contains an F-Type isolated (floating) applied part providing a high degree of protection against shock, and is defibrillator-proof.
Attention! Please refer to the document supplied with this instrument (this manual)!
Potential equalization conductor terminal
Dangerous voltage
AC/Battery power indicator
Base on the requirements of safety and anti-interference, the monitor must be connected with potential equalization system individual. Connect the Potential equalization conductor terminal to the potential equalization system with the green and yellow potential equalization cable. If the protection earth system is damaged, the potential equalization system can take on the safety function of protection earth conductor.
Fuse specs: T3.0AL250V Φ5×20 mm

1.4.4 Notes on the signs on the monitor

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Defibrillator user’s manual
Battery charge indicator
Non-ionizing radiation
Auxiliary output
ECG
Short for “Electrocardiogram”.
RESP
Short for “Respiration”
Symbol for the marking of electrical and electronics devices according to Directive 2002/96/EC. The device, accessories and the packaging have to be disposed of waste correctly at the end of the usage. Please follow Local Ordinances or Regulations for disposal.
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Defibrillator user’s manual

Chapter 2 Important Safety Notes

Warning: PACEMAKER PATIENTS. Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter ALARMS. Keep pacemaker patients under close surveillance. See this manual for disclosure of the pacemaker pulse rejection capability of this instrument.
Warning: Only trained doctors and nurses can use the device.
Warning: The Monitor is not a therapeutic instrument nor is it a device that
can be used at home.

2.1 General Safety

1. Safety precautions for safe installation
The AC input socket of the monitor can be connected to the electrical wires and
common electrical wire can be used.
Only the power supply type of AC 100V~240V 50/60Hz specified by the Monitor
can be used.
Connect the electrical wire to a properly grounded socket. Avoid putting the socket
used for it in the same loop of such devices as the air conditioners, which regularly
switch between ON and OFF.
Avoid putting the monitor in the locations where it easily shakes or wobbles.
Enough room shall be left around the monitor so as to guarantee normal ventilation.
Make sure the ambient temperature and humidity are stable and avoid the
occurrence of condensation in the work process of the monitor.
Warning: Never install the monitor in an environment where flammable
anesthetic gas is present.
2. The Monitor conforms to the safety requirements of IEC 601-1:1988. The Monitor is
protected against defibrillation effects.
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3. Notes on signs related to safety
Defibrillator-proof type CF equipment (refer to IEC 60601-2-27)
The unit displaying this symbol contains an F-Type isolated (floating)
applied part providing a high degree of protection against shock, and
is defibrillator-proof.
The type CF applied parts provide a higher degree of protection
against electric shock than that provided by type BF applied parts.
Attention! Please refer to the documents accompanying this monitor
(this manual)!
Defibrillator user’s manual
4. When a defibrillator is applied on a patient, the monitor may have transient disorders in
the display of waveforms. If the electrodes are used and placed properly, the display of
the monitor will be restored within 10 seconds. During defibrillation, please note to
remove the electrode of chest lead and move the electrode of limb lead to the side of the
limb. The electrode of the defibrillator should not come into direct contact with the
monitoring electrodes. Please ensure the monitor is reliably grounded and the electrodes
used repeatedly should be kept clean.
Warning: When conducting defibrillation, do not come into contact with the
patient, the bed and the monitor. Otherwise serious injury or death could be
resulted in.
5. To guarantee the safe operation of the monitor, the Monitor is provided with various
replaceable parts, accessories and consuming materials (such as sensors and their cables,
electrode pads). Please use the products provided or designated by the manufacturer.
6. The Monitor only guarantees its safety and accuracy under the condition that it is
connected to the devices provided or designated by manufacturer. If the monitor is
connected to other undesignated electrical equipment or devices, safety hazards may
occur for causes such as the cumulating of the leakage current.
7. To guarantee the normal and safe operation of this monitor, a preventive check and
maintenance should be conducted for the monitor and its parts every 6-12 months
(including performance check and safety check) to verify the instrument can work in a
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Defibrillator user’s manual
safe and proper condition and it is safe to the medical personnel and the patient and has
met the accuracy required by clinical use.
Caution: The Monitor does not contain any parts for self-repair by users. The repair of the instrument must be conducted by the technical personnel been authorized by manufacturer.

2.2 Some important notes for safety

PATIENT NUMBER
The Monitor can only be applied to one patient at one time.
INTERFERENCE
Do not use cellular phone in the vicinity of this equipment. High level of electromagnetic radiation emitted from such devices may result in strong interference with the monitor performance.
ACCIDENTAL SPILLS
To avoid electric shock or device malfunction, liquids must not be allowed to enter the device. If liquids have entered the device, take it out of service and have it checked by a service technician before it is used again.
ACCURACY
If the accuracy of any value displayed on the monitor or printed on a printout paper is questionable, determine the patient’s vital signs by alternative means. Verify that all equipment is working correctly.
ALARMS
Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in a hazard to the patient. Remember that the most reliable method of patient monitoring combines close personal surveillance and correct operation of monitoring equipment.
The functions of the alarm system for monitoring the patient must be verified at regular intervals.
BEFORE USE
Before putting the system into operation, please visually inspect all connecting cables for signs of damage. Damaged cables and connectors must be replaced immediately.
Before using the system, the operator must verify that it is in correct working order and operating condition.
Periodically, and whenever the integrity of the product is in doubt, test all functions.
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Defibrillator user’s manual
CABLES
Route all cables away from patient’s throat to avoid possible strangulation.
DISCHAGE TO CLEAR PATIENT DATA
When monitoring a new patient, you must clear all previous patient data from the system. To accomplish this, shut down the device, then turn on it.
DISPOSAL OF PACKAGE
Dispose of the packaging material, please observe the applicable waste control regulations and keep it out of children’s reach.
EXPLOSION HAZARD
Do not use this equipment in the presence of flammable anesthetics, vapors or liquids.
LEAKAGE CURRENT TEST
When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients.
BATTERY POWER
The device is equipped with a battery pack. The battery discharges even when the device is not in use. Store the device with a fully charged battery and take out the battery, so that the service life of the battery will not be shortened.
DISPOSAL OF ACCESSORIES AND DEVICE
Disposable devices are intended for single use only. They should not be reused as performance could degrade or contamination could occur.
The service life of this monitor is five years. At the end of its service life, the product described in this manual, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have questions concerning disposal of products, please contact us.
EMC
Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason, make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements. X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. Also, keep cellular phones or other telecommunication equipment away from the monitor.
INSTRUCTION FOR USE
For continuous safe use of this equipment, it is necessary that listed instructions were followed. However, instructions listed in this manual in no way can supersede established medical practices concerning patient care.
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Defibrillator user’s manual
Type of protection against electric shock:
I
Degree of protection against electric shock:
CF: ECG, RESP
Degree of protection against harmful ingress of water:
Ordinary Equipment (enclosed equipment without protection against ingress of water)
Degree of safety of application in the presence of a flammable anesthetic-mixture with air or with oxygen or nitrous oxide:
Not suitable
Mode of operation:
Continuous operation
Method(s) of sterilization or disinfection recommended by the manufacturer:
Sterilization: not applicable
Disinfection: See “The Maintenance and Cleaning of the System->General Cleaning”
Electromagnetic interference
No cellular telephone nearby
Electro surgical interference damage
No damage
Diathermy instruments influence
Displayed values and prints may be disturbed or erroneous during diathermy.
Defibrillation shocks
The Monitor specifications fulfill the requirements of IEC 601-1, IEC 60601-2-27, IEC 60601-2-49.
Auxiliary outputs
The system must fulfill the requirements of standard IEC 60601-1-1.
LOSS OF DATA
Should the monitor at any time temporarily lose patient data, close patient observation or alternative monitoring devices should be used until monitor function is restored.
If the monitor does not automatically resume operation within 60 seconds, restart the monitor using the power on/off switch. Once monitoring is restored, you should verify correct monitoring state and alarm function.

2.3 Classifications

The Monitor is classified, according to IEC601-1: 1988 as:
I: Class I equipment CF: Type CF applied part Not suitable: Equipment not suitable for use in the presence of flammable anesthetic
mixture with air or with oxygen or nitrous oxide.

2.4 Safe Operating and Handling Conditions

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Defibrillator user’s manual

Chapter 3 Getting Started

3.1 Open the Package and Check

Unpack the packaging case
Open the packaging case and the accessory box, accessories include electrical wire,
various patient sensors and user’s manual (this manual), warranty card, certificate and
particular paper and the foam case contains the monitor.
Remove the monitor and accessories
Caution: please place the monitor on level and stable supporting plane, not on
the places that can easily shock or wake. Enough room should be left around the
monitor so as to guarantee normal ventilation.
Keep all the packaging materials for future use in transportation or storage.
Check the monitor and accessories
Check the monitor and its accessories one by one in accordance with the particular
paper. Check to see if the parts have any mechanical damages. In case of problems,
please contact us or our agent.

3.2 Connect Power

3.2.1 AC Power

Confirm the rated AC current is: AC 100V~240V 50/60Hz
Use the electrical wires provided along with the instrument, put its output end plug
(round headed) into the AC current socket on the back of the monitor, and the plug of
input end into a grounded socket of the mains (It must be a special socket of the hospital),
connect the monitor through the earth one of electrical wires.
When the AC indicating light beside the power switch on the panel of the monitor is
green, it means the AC power is on. And when the monitor is not connected to AC power
and the built-in DC battery is used as the power source, the indicating light is orange.
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