MEC-1000 Multi-parameter Monitor Operator’s Manual Ver 3.1 July 2005

Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rent, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

,

,

,

and

are the registered

trademarks or trademarks owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners. Contents of this manual are subject to changes without prior notice.

For this Operation Manual, the issued Date is July 2005 (Version: 1.3). © 2002-2005 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

I

Manufacturer’s Responsibility All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for safety, reliability and performance of this product only in the condition that: all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel; and, the electrical installation of the relevant room complies with the applicable national and local requirements; and, this product is operated under strict observance of this manual.

Warranty This warranty is exclusive and is in lieu of all other warrantyies, expressed or implied, including warranties of merchantability or fitness for any particular purpose.

Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to any Mindray product which has been subjected to misuse, negligence or accident; or any Mindray product from which Mindray's original serial number tag or product identification markings have been altered or removed; or any product of any other manufacturer.

II

Return Policy In the event that it becomes necessary to return a unit to Mindray, follow the instructions below.

1.

Obtain a return authorization.

Contact the Mindray Service Department and obtain a Mindray Customer Service Authorization Number. The Mindray Customer Service Authorization Number must appear on the outside of the shipping container. Return shipments will not be accepted if the Mindray Customer Service Authorization Number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return.

2.

Freight policy

The customer is responsible for freight charges when this product is shipped to Mindray for service (including any relevant customs fees or other freight related charges).

3.

Return address

Please send the part(s) or equipment to the address offered by Customer Service Department.

III

Contact Information Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address:

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen 518057 P.R. China

Tel:

+86 755 26522479

+86 755 26582888

Fax:

+86 755 26582500

+86 755 26582501

Website:

www.mindray.com.cn

EC Representative:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestraße 80, 20537 Hamburg Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

IV

Equipment Symbols This symbol means 'BE CAREFUL '. Refer to the manual. This symbol indicates that the instrument is IEC 60601-1 Type CF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock, and is suitable for use during defibrillation.

Equipotential grounding system. Protective earth ground.

Power On/Off This mark means that this device is fully in conformance with the Council Directive Concerning Medical Devices 93/42/EEC. The number adjacent to the CE marking (0123) is the number of the EU-notified body that certified meeting the requirements of Annex II of the Directive. The following definition of the WEEE label applies to EU member states only. This symbol indicates that this product should not be treated as household waste. By ensuring that this product is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health. For more detailed information with regard to returning and recycling this product, please consult the distributor from whom you purchased it. * For system products, this label may be attached to the main unit only. NOTE: Points to be noted. CAUTION: Points to be noted to avoid damage to the equipment. WARNING: Points to be noted to avoid injury to the patient and the operator.

V

FOR YOUR NOTES

VI

Contents Chapter 1

Introduction... 1-1

1.1 General Information ... 1-2 1.2 Screen Display ... 1-4 1.3 Button Functions ... 1-7 1.4 Interfaces ... 1-10 1.5 Built-in battery ... 1-12 Chapter 2

Getting Started ... 2-1

2.1 Unpacking and Checking ... 2-1 2.2 Connect the Power Cables ... 2-1 2.3 Power On the Monitor ... 2-2 2.4 Connect Sensors/Probes ... 2-2 2.5 Check the Recorder ... 2-2 Chapter 3

System Menu ... 3-1

3.1 Patient Setup ... 3-2 3.2 Default Setup... 3-4 3.3 System Setup ... 3-5 3.4 Selection Setup ... 3-10 3.5 Monitor Version ... 3-11 3.6 Drug Calculation... 3-12 3.7 Maitenance ... 3-12 3.8 DEMO Function... 3-15 Chapter 4

Face Select ... 4-1

4.1 Standard Screen ... 4-1 4.1 Viewbed Screen ... 4-2 Chapter 5

Alarm... 5-1

5.1 Alarm Modes ... 5-1 5.2 Alarm Self-test... 5-4 5.3 Alarm Cause... 5-4 5.4 SILENCE/CLOSE/PAUSE ... 5-5 5.5 Parameter Alarm ... 5-6 5.6 When an Alarm Occurs ... 5-6 Chapter 6

Freeze ... 6-1

6.1 General Description ... 6-1 6.2 Entering and Exiting Frozen Mode... 6-1 6.3 Frozen Menu ... 6-2 6.4 Recording Frozen Waveform ... 6-2 Chapter 7

Recording ... 7-1

7.1 General Description ... 7-1 7.2 Recording Type ... 7-1 7.3 Start Recording ... 7-4 1

Contents

7.4 Recorder Operations and Status Information ... 7-5 Chapter 8

Trend and Event ... 8-1

8.1 Trend Graph ... 8-1 8.2 Trend Table... 8-3 8.3 NIBP Recall ... 8-5 8.4 Alarm Event Recall ... 8-5 Chapter 9

Drug Calculation and Titration Table... 9-1

9.1 Drug Calculation... 9-1 9.2 Titration Table ... 8-4 Chapter 10

Patient Safety... 10-1

Chapter 11

Maintenance / Cleaning ... 11-1

11.1 System Check ... 11-1 11.2 General Cleaning ... 11-1 11.3 Cleaning Agents ... 11-2 11.4 Sterilization ... 11-3 11.5 Disinfection... 11-3 Chapter 12

ECG/RESP Monitoring ... 12-1

12.1 What Is ECG Monitoring ... 12-1 12.2 Precautions ... 12-1 12.3 Monitoring Procedure... 12-2 12.4 ECG Screen Hot Keys ... 12-5 12.5 ECG Menu ... 12-6 12.6 ECG Alarm Information and Prompt ... 12-10 12.7 ST Segment Monitoring (optional) ... 12-11 12.8 Arr. Monitoring (optional)... 12-15 12.9 Measuring RESP... 12-20 12.10 Maintenance and Cleaning ... 12-24 Chapter 13

SpO2 Monitoring ... 13-1

13.1 What is SpO2 Monitoring... 13-1 13.2 Precautions ... 13-2 13.3 Monitoring Procedure... 13-3 13.4 Limitations for Measurement... 13-5 13.5 SpO2 Menu... 13-6 13.6 Alarm Description and Prompt ... 13-8 13.7 Maintenance and Cleaning ... 13-9 Chapter 14

NIBP Monitoring... 14-1

14.1 Introduction ... 14-1 14.2 NIBP Monitoring ... 14-1 14.3 NIBP SETUP menu... 14-6 14.4 NIBP Alarm Message ... 14-11 14.5 Maintenance and Cleaning ... 14-13 Chapter 15

TEMP Monitoring ... 15-1

15.1 TEMP Monitoring ... 15-1 15.2 TEMP SETUP Menu ... 15-2

2

Contents

15.3 TEMP Alarm message ... 15-3 15.4 Maintenance and Cleaning ... 15-3 Chapter16

Accessories and Ordering Information ... 16-1

16.1 ECG Accessories ... 16-1 16.2 SpO2 Accessories ... 16-2 16.3 NIBP Accessories... 16-2 16.4 TEMP Accessories ... 16-3

Appendix A EC Declaration of Conformity...A-1 Appendix B Product Specification ...B-1 Appendix C EMC...C-1 Appendix D System Alarm Prompt ...D-1

3

Contents

FOR YOUR NTOES

4

Chapter 1 Introduction For an overview of the monitor, refer to 1.1 General Information. For various messages displayed on the screen, refer to 1.2 Screen Display. For basic operations, please refer to 1.3 Button Functions. For allocation of interface sockets, please refer to 1.4 Interfaces. For battery recharging procedure, refer to 1.5 Built-in Battery. For safety precautions of the monitor, refer to Chapter 10 Patient Safety.

Warning The Monitor is intended for use by qualified clinical Personnel. Its operation is to be performed by a physician or appropriate medical staff under the direction of a physician. The monitor can monitor single patient once. Opening the monitor housing presents a risk of hazard due to electrical shock. All servicing and future upgrades to this equipment must be carried out by personnel trained and authorized by Mindray. Possible explosion hazard if used in the presence of flammable anesthetics. You must verify if the device and accessories can function safely and normally before use. You must customize the alarm setups according to individual patient situation and make sure that alarm sound can be activated when alarm occurs. Do not use cellular phone in the vicinity of this device. High level electromagnetic radiation emitted from such devices may greatly affect the monitor performance. Do not touch the patient, table, or the device during defibrillation. Devices connected to the monitor shall form an equipotential system (protectively earthed). When used with Electro-surgery equipment, you (doctor or nurse) must give top priority to the patient safety. Dispose of the packaging material, observing the applicable waste control regulations 1-1

Introduction

and keeping it out of children’s reach.

Note This equipment complies with the standard CISPR11 (EN55011) class A. The software was developed per IEC601-1-4. The possibility of hazards arising from errors in the software program is minimized. Caution 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 regulation the disposal of such products. If you have questions concerning disposal of the product, please contact Mindray Customer Service.

1.1

General Information

Environmental Specifications Temperature Working

0 ~ 40 °C

Transport and Storage -20 ~ 60 °C Humidity Working

15% ~ 95%, noncondensing

Transport and Storage 10% ~ 95%, noncondensing Altitude Working

-500 ~ 4,600m

Transport and Storage -500 ~ 13,100m Power Supply 100 ~ 240V, AC, 50/60Hz Pmax=110VA FUSE T 1.6A Contraindications: None

Note The system may not meet its performance specifications if stored or used outside the specified temperature and humidity range.

General Instruction The Monitor is applicable for bedside monitoring of Adult, Pediatric and Neonate. The Monitor is intended to monitor vital signals such as ECG, Respiratory Rate, SpO2, NIBP and TEMP. It integrates parameter measurement, display and recorder in one device, featured by compactness, lightweight and portability. Its large and high-resolution display can clearly display 4 waveforms and all parameter information. 1-2

Introduction

Front Panel ③

②

⑤ ①

④ Figure 1-1

Patient Monitor

① POWER Switch: On the bottom left quarter of the front panel. ② CHARGE Indicator: A LED above the POWER Switch. ③ ALARM Indicator: A LED on the upper side of the front panel. The ALARM indicator flashes or lights when an alarm occurs. The visible LEDs are CLASS 1 LED PRODUCT according with EN 60825-1 A11 Oct 1996. ④ Control Panel: Refer to 1.3 Button Functions for details. ⑤ Rotary Knob: Refer to 1.3 Button Functions for details. The sockets of the sensors are at the left side. The recorder socket is at the right side. Other sockets and power plug-in are at the rear panel.

Monitored Parameters Heart Rate (HR) ECG

1-channel ECG waveform Arrhythmia and S-T segment analysis, Pace analysis

RESP

SPO2

Respiratory Rate (RR) Respiration Waveform Oxygen Saturation (SpO2), Pulse Rate (PR) SpO2 Plethysmogram

NIBP

Systolic Pressure (NS), Diastolic Pressure (ND), Mean Pressure (NM)

TEMP

Temperature DATA

The monitor has additional functions including visual & audible alarm, trend data storage and output, NIBP data storage and review, alarm event identification, and drug calculation. 1-3

Introduction

1.2

Screen Display

The display of the monitor is a color TFT, Which can display the collected patient parameters, waveforms, alarm information as well as bed number, time and monitor status, etc. As shown in Figure 1-2, the main screen is divided into three areas: ①

②

③

① Figure 1-2

Main Screen

① Message Area; ② Waveform Area; ③ Parameter Area.

① Message Area The Message Area is at top and bottom part of the screen, displaying the current status of both the monitor and the patient. The top part displays “patient information”, “monitoring status” and “alarm message” from left to right. The “monitoring status” and “alarm message” appear or disappear together with the status being reported. Patient information include: BED NO

Bed numbers of all patients under monitoring

Patient type

Three options: Adult, Pediatric, Neonate

“2000-01-08”

Current date: “year - month - day”

“00:49:30”

Current time: “hour : minute : second”

Patient name

This item will display blank if the operator does not input patient name

Patient sex

Male of Female

Monitoring status reporting the current status of the monitor or sensor/probe, which always appears to the right side of the system time. When this information appears, it will cover patient sex and name. 1-4

Introduction

Alarm message icon for alarm PAUSE. Press “SILENCE” button once (less than 1 second) to suspend all alarm sounds for the pause duration. Press the button again to terminate the PAUSE status. The duration for PAUSE status can be set for 1 minute, 2 minutes, or 3 minutes.

icon for alarm SILENCE. Press and hold the “SILENCE” button for more than 1 second to manually mute the alarm sound and this icon will be displayed. The SILENCE status terminates when you press “SILENCE” button again or new alarm occurs.

icon for Alarm Volume Off. It appears indicating that you have turned the alarm sound OFF. To terminate this function, you must turn the Alarm Volume ON.

Note If the

symbol appears, the system will no longer give an audible alarm sound.

You must be very careful in using this function.

② Waveform/Menu Area This area can display four waveforms under normal operation mode. From the top to the bottom, there are 2 ECG waveforms (one-channel cascade ECG waveform), SpO2 Plethysmogram waveform, and RESP waveform. You can choose the waveforms for display. Refer to 3.3.6 Tracing Waveforms Selection for details. The gain, channel as well as filter way of the ECG waveform are also displayed above the ECG waveform. A 1mv scale bar is displayed to the right side of the ECG waveform for reference. The name of other waveform is displayed at the upper left of the waveform. When the functional menu is accessed during normal monitoring operation, the menu always occupies a fixed position in the middle part of the waveform area. Therefore, part of the waveform can’t be viewed. After exiting the menu, the monitor will return to the original display. You may select the refresh rate for the waveforms. The method to adjust the refresh rate for each waveform is discussed in the setup description for each parameter.

③ Parameter Area Parameters are displayed on the right side of the waveform area, and their positions basically 1-5

Introduction

correspond to the waveform. The measured parameters displayed in this area include: ①HR or PR ②ST Anlysis ③PVC ④NIBP

⑤SPO2 ⑥RESP ⑦TEMP

Figure 1-3

Main Screen

ECG: ⎯ ① Heart Rate ( Unit: bpm) ⎯ ② ST-segment analysis result (Unit: mV) ⎯ ③ Arrhythmia (PVCs) events (Unit: event/min) NIBP: - ④ Systolic, Mean, Diastolic (From left to right) (Unit: mmHg or kPa) SpO2: ⎯ ⑤ SpO2 (Unit: %) RESP: ⎯ ⑥ Respiration Rate (Unit: breath/min) TEMP: ⎯ ⑦ Temperature (Unit:℃ or ℉) The system refreshes each parameter value once per second except NIBP, which is refreshed after each measurement.

Alarm indicator and status During normal monitoring, the alarm indicator is not on. When an alarm occurs, the alarm indicator lights on or flashes. The color of the indicator corresponds to the alarm priority level. Refer to Chapter 5 Alarm for detailed information. For the details of the alarm and alarm message information for the individual measured parameters, refer to the chapter for each parameter.

1-6

Introduction

Warning Always verify the self-check function of the audible and visual (LED) alarms when the power is turned on.

1.3

Button Functions

The operation of the monitor is performed using a few buttons and a Rotary Knob on the control panel, located at the lower right of the monitor.

①

②

③

Figure 1-4

④

⑤

⑥

⑦

Buttons and Knob

① MAIN The screen will return to the main screen when this button is pressed. ② FREEZE Press this button and the monitor will switch to the FREEZE mode. Press this button again to exit the FREEZE mode. In FREEZE mode, the frozen waveform can be printed out. For detailed information, refer to Chapter 6 Freeze. ③ SILENCE Press this button to access the Alarm Pause status. All the alarm sounds are muted. However, other sounds such as heart beat, button sound and pulse sound will still exist. At this time, the “ALARM PAUSE xx s” appears in the parameter alarm information area. Press this button again or when the pause time runs out, the system terminates the alarm pause status and returns to the normal monitoring status, then the alarm sound resumes and the prompt “ALARM PAUSE xx s” disappears from the screen.

Note When the monitor exits the Alarm Pause status, whether the alarm sound is restored depends on whether the alarm exists. However, the technical alarms such as lead off will not be restored. That means the user may also close the technical alarms such as lead off through accessing and then exiting the Alarm Pause status. Press this button for more than 1 second to access the Silence status. The system will mute all kinds of sound such as heart beat, pulse and button sound and all the current alarm sound will be muted. The symbol

appears in the information area. Press the

SILENCE once again to restore all kinds of sound and the

1-7

disappears.

Introduction

In the Alarm Silence status, if there is new alarm, the system will terminate the Silent status and restore the normal alarming status. At this time, the system gives alarm according to the setup alarm sound. For the detailed rules, refer to related chapter: Alarm. ④ RECORD Press this button to start a real time recording. The recording time is set in REC TIME of RECORD SETUP submenu. Press during recording to stop the recording. For detailed information, refer to Chapter 7 Recording. ⑤ START Press this button to inflate the cuff to start a blood pressure measurement. When measuring, press to cancel the measurement and deflate the cuff. ⑥ MENU Press this button to display the SYSTEM MENU, in which the user may set up system information and perform review operation. For detailed information, refer to Chapter 3 System Menu and Chapter 8 Trend and Event. ⑦ Rotary Knob Use the rotary knob to select menu items and modify the monitor setup. It can be rotated clockwise or counter-clockwise, and pressed to make a desired selection, similar to other buttons.

How to use the Rotary Knob The rectangular mark on the screen that moves with the rotation of the knob is called a “cursor”. Operation can be performed at any position at which the cursor is located. When the cursor is in the waveform area, you may immediately modify the current setup by selecting one of the following hot keys: ECG lead name ECG gain ECG filter When the cursor is in the parameter area, you may open the setup menu of the corresponding parameter to review or change the menu items. ECG menu NIBP menu SpO2 menu RESP menu TEMP menu Highlight any item that you want to operate and press the knob, the system will fulfill one of the following three activities: A menu pops up, or the current menu is replaced by a new one; The solid frame becomes a dotted one, indicating that rotating the knob can change its content;

1-8

Introduction

The system can immediately execute an operation.

Basic Operations To display desired waveform: Press the MENU button to access the SYSTEM MENU and then select the [TRACE SETUP] item. The TRACE SETUP menu will appear, in which you can select the desired waveform. Refer to 3.3.6 Tracing Waveforms Selection for details. To adjust waveform sweep speed: ECG: access the ECG SETUP menu and select the [SWEEP] item; PLETH: access the SpO2 SETUP menu and select the [SWEEP] item; RESP: access the RESP SETUP menu and select the [SWEEP] item. To change Alarm limits: ECG: access the ECG SETUP menu and select the [ALM HI] or [ALM LO] item. ST: access the ECG SETUP menu and select the [ST ANALYSIS], then select the [ALM HI] or [ALM LO] item. PVCs: access the ECG SETUP menu and select the [ARR ANALYSIS], then select the [ALM HI] or [ALM LO] item. SpO2: access the SPO2 SETUP menu and select the [SpO2 ALM HI] or [SPO2 ALM LO] item. PR: access the SPO2 menu and select the [PR HI] or [PR ALM LO] item. NIBP Systolic: access the NIBP SETUP menu and select the [SYS ALM HI] or [SYS ALM LO] item. NIBP MEAN: access the NIBP SETUP menu and select the [MEAN ALM HI] or [MEAN ALM LO] item. NIBP Diastolic: access the NIBP SETUP menu and select the [DIA ALM HI] or [DIA ALM LO] item. RESP: access the RESP SETUP menu and select the [ALM HI] or [ALM LO] item. TEMP: access the TEMP SETUP menu and select the [ALM HI] or [ALM LO] item. To record real-time waveform: Push RECORD button to start the real-time recording process. Refer to Chapter 7 Recording for details. To adjust volume: Alarm volume: Press the MENU button to access the SYSTEM MENU SYSTEM SETUP ALARM SETUP and select the [ALARM VOL] item. Key volume: Press the MENU button to access the SYSTEM MENU SELECTION and select the [KEY VOL] item. Beat volume: Access the ECG SETUPOTHER SETUPS and select the [BEAT VOL]. You can select 0~10. 1-9