Mindray DPM 1 Operator'S Manual Download Page 48

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A-4

Impact:

Meets the requirements of ECRI PB-296 892, AIII 3.2 (the part

against Class III instruments).

Spillage and ingress of

liquid:

Meets the requirements of IEC 60601-1-1, clause 44.3 and IEC

60601-27, clauses 30 and 34. It also meets the IEC 529

requirements for IPX0 devices.

Surface temperature:

Meets the requirements of IEC 60601-1, clauses 42.1, 42.2 and

42.3.

Meets the requirements of FDA Reviewer Guidance for Premarket

Notification Submission, November 1993, paragraph i7.

Mechanical stability:

Meets the requirements of IEC 60601-1, clause 24.1.

Incompatibility with external

connectors

Meets the requirements of IEC 60601-1, clause 56.3 and of FDA

Reviewer Guidance for Premarket Notification Submission

November1993, i2.

Enclosure rigidity and

strength

Meets the requirements of IEC 60601-1, clause 21a, 16a and 21b.

Meets the requirements of UL 2601-1, clause 55.

Deterioration of heat

radiation conditions

Meets the requirements of IEC 60601-1, clause 52.5.5.

Leakage current

Meets the requirements of IEC 60601-1/EN 60601-1, Clause 19.

Dielectric strength

Meets the requirements of IEC 60601-1/EN 60601-1, Clause 20.

Summary of Contents for DPM 1

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Page 3: ...ver without the written permission of Mindray DS is strictly forbidden Release amendment reproduction distribution rental adaption and translation of this manual in any manner whatsoever without the written permission of Mindray DS is strictly forbidden is a trademark or a registered trademark of Shenzhen Mindray Bio Medical Electronics Co Ltd All third party trademarks that appear in this manual ...

Page 4: ...the instructions for use Warranty This warranty is exclusive and is in lieu of all other warranties expressed or implied including warranties of merchantability or fitness for any particular purpose Exemptions Mindray DS 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 fro...

Page 5: ...mber 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 DS for service this includes customs charges 3 Return address Please send the part s or equipment to the address offered by the Customer Service Department Contact Informat...

Page 6: ... monitoring patients Version Information This manual has a version number This version number changes whenever the manual is updated due to software or technical specification change Content of this manual is subject to change without prior notice The version information of this manual is as follows Version number Release date 3 0 2010 04 Illustrations and Names All illustrations in this manual ar...

Page 7: ... Button 2 4 2 6 3 Confirm ID Button 2 4 2 6 4 Delete ID Button 2 4 3 Installation 3 1 3 1 Unpacking and Inspection 3 1 3 2 Install Batteries 3 1 3 3 Power on 3 2 3 4 Connect SpO2 Sensor 3 2 3 5 Connect Computer 3 3 4 Measurement 4 1 4 1 Measuring Principle 4 1 4 2 Precautions 4 1 4 3 Measuring Steps 4 2 4 3 1 Adult Measurement 4 2 4 3 2 Neonatal Measurement 4 3 4 3 3 Placing Neonatal SpO2 Sensor 4...

Page 8: ... Disposal 6 3 7 Pulse Oximeter Management System 7 1 7 1 Installation and Uninstall 7 1 7 1 1 Installation 7 1 7 1 2 Uninstall 7 2 7 2 Main Interface 7 2 7 2 1 Menu Bar 7 3 7 2 2 Tool Bar 7 4 7 2 3 Data Area 7 5 7 3 Functions 7 5 7 3 1 Data Output 7 5 7 3 2 Software Upgrade 7 6 7 3 3 File Management 7 8 7 3 4 Modify Patient Information 7 9 7 3 5 Print Data 7 9 7 3 6 Prompt Message 7 10 8 Accessori...

Page 9: ...which may be the same as or similar to the followings or specific to the operations WARNING z Indicates a potential hazard or unsafe practice that if not avoided could result in death or serious injury CAUTION z Indicates a potential hazard or unsafe practice that if not avoided could result in minor personal injury or product property damage NOTE z Provides application tips or other useful inform...

Page 10: ...intenance schedule may cause undue device failure and possible health hazard z When using DPM1 together with the electrical surgery equipment the user should pay attention to and guarantee safety of the patient being measured z Do not pull or lift DPM1 by its connection cable That may lead to falling and consequent patient injuries z Magnetic and electrical fields are capable of interfering with t...

Page 11: ...d in this manual z DPM1 is a commonly sealed device Keep its surface dry and clean and prevent any liquid from infiltrating it z Don t use mobile phones around when DPM1 is in operation z DPM1 should only be maintained by personnel approved by our company z Before using DPM1 on patients the user should be familiar with its operation 1 1 3 Notes NOTE z Important Before use carefully read this manua...

Page 12: ...ld 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 ...

Page 13: ...ton and Confirm ID button DPM1 is also capable of managing measured data and transmitting the patient s trend through the dual purpose socket to a PC for printing 2 2 Contraindications None 2 3 Functions DPM1 has the following functions Measuring SpO2 PR and pulse strength Prompting Memory full ID full low battery standby and technical error etc Power managing automatic standby automatic shutdown ...

Page 14: ...rns on or off the device 4 Confirm ID It confirms the patient ID for current measurement 5 Delete ID A key combination of 4 and 6 6 Backlight It turns on or off the backlight 7 Caution Refer to this manual 8 Battery door Open it to install or remove batteries 2 5 Displayed Information The figure below shows information displayed on DPM1 s screen Figure 2 3 Displayed Information Table 2 2 Descripti...

Page 15: ...ttery It appears only when the battery energy is low 2 6 Button Operation Three soft buttons are available on DPM1 s front panel Power Backlight Confirm ID Figure 2 4 Buttons 2 6 1 Power Button Power on Press to turn on the device Power off Press and hold for two seconds to turn off the device NOTE z DPM1 is powered by batteries only Please install batteries before use as described in 3 2 Install ...

Page 16: ... to add data It enables the user to add data without using a new ID number to a re test for the same patient after the sensor is accidentally disconnected Refer to section 5 1 Data Management for detailed use of this button 2 6 4 Delete ID Button The Delete ID button is a key combination of the Backlight button and the Confirm ID button Refer to section 5 1 Data Management for detail use of this b...

Page 17: ...e of any problem NOTE z Please save the packing case and packaging material for future transport and storage WARNING z Be sure to keep the packaging materials from children s reach z Disposal of the packaging materials shall comply with your local requirements 3 2 Install Batteries DPM1 is powered by four batteries Follow the steps below to install batteries before use 1 Hold DPM1 in one hand 2 Pl...

Page 18: ...ges or even personnel injuries z Only the operator can remove the battery cover 3 3 Power on Press the Power button to turn on DPM1 The startup interfaces and version information will be displayed and then the initialization interface of DPM1 as shown in Figure 3 3 will be displayed After that DPM1 will automatically switch to the standby mode as shown in Figure 3 4 Figure 3 3 Figure 3 4 3 4 Conne...

Page 19: ...able to transmit patient s trend to the computer for printing Simply connecting one end of the PC communication cable to DPM1 s dual purpose socket and the other end to the PC s serial port This symbol will be displayed in the LCD screen indicating that DPM1 has connected with the PC successfully ...

Page 20: ...3 4 FOR YOUR NOTES ...

Page 21: ... on the same arm simultaneously Obstruction of blood flow during NIBP measurements may adversely affect the reading of the SpO2 value z A measurement shall last longer than 15 seconds Otherwise new data of next measurement can t be added to the same patient z DPM1 is not recommended for prolonged monitoring WARNING z Check if the sensor cable is in normal condition before monitoring Do not use the...

Page 22: ...t depends on the patient type For an adult patient you can choose a finger SpO2 sensor for an infant patient you can choose a hand or toe sensor Refer to the following procedure 4 3 1 Adult Measurement Please follow the steps below to use the adult finger SpO2 sensor 1 Insert the sensor s connector to DPM1 s dual purpose socket 2 Turn on DPM1 to enter the standby mode 3 Attach the sensor to an app...

Page 23: ...atal SpO2 Sensor 2 Wind the SpO2 sensor around a hand or foot of a neonate patient Hold the sensor pull the belt and fit one of its sides with V edge into the V groove on the corresponding side of the sheath Appropriately elongate the belt to about 20mm and fit the V edge of the other side of the belt into the V groove of the other side of the sheath Then loosen the belt After the V edges of the t...

Page 24: ...n lamps fluorescent lights infrared heating lamps or direct sunlight exposure to excessive illumination can be corrected by covering the sensor with a dark material Excessive patient motion Venous pulsations Placement of a sensor on the same extremity with a blood pressure cuff arterial catheter or intravascular line Loss of pulse signal can occur in the following situation The sensor is too tight...

Page 25: ... ID Minimum PR value of this ID Average PR value of this ID Trend Data Zone is capable of storing 200 trend data TD as shown below at most When the number exceeds 200 new data will automatically cover the old data from the earliest stored data TD 001 TD 002 TD 003 TD 200 The first trend data will be stored 15 seconds after the pulse is found Thereafter one trend data will be stored every 2 minutes...

Page 26: ...rotection function When the power is turned off accidentally during the process of storing a data DPM1 will evaluate completeness of the last stored data when it is restarted If the data is complete it will be validated otherwise it will be invalidated 5 1 4 Data Deletion Press the Delete ID button in the standby mode the message DELETE ALL will be displayed as shown in Figure 5 1 Figure 5 1 Figur...

Page 27: ...tion The device is in communication mode None DELETE ALL The Delete ID button is pressed Refer to 5 1 4 Data Deletion ALL DELETED The Delete ID button is pressed again after DELETE ALL appears None DPM1 can also display technical error messages In Table 5 2 error messages as well as their causes and solutions are listed If the LCD screen can t display anything it may be damaged or error occurs dur...

Page 28: ...s by switching to the standby mode automatically when the finger disconnects from the sensor or the sensor disconnects from DPM1 shutting down automatically if no finger is inserted into the sensor within 5 minutes under the standby mode NOTE z DPM1 will automatically switch from the standby mode to the normal operation mode when a finger is inserted into the sensor z Please refer to 7Pulse Oximet...

Page 29: ...tely WARNING z Failure on the part of the responsible hospital or institution employing the use of the monitoring equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazard z The safety inspection or maintenance which requires opening the monitor housing must be performed by trained and authorize personnel only Otherwise equipment failur...

Page 30: ...cleaners or cleaners containing acetone Failure to follow these rules may erode or fray the casing or blur lettering on the labels or cause equipment failures For cleaning information of accessories please refer to the instructions for use of the accessories 6 3 Disinfection Disinfection may cause damage to the equipment We recommend the disinfection be contained in the hospital s servicing schedu...

Page 31: ... avoid contaminating or infecting personnel the environment or other equipment make sure you disinfect or decontaminate the device appropriately before disposing of it in accordance with your country s law for equipment containing electrical and electronic parts For SpO2 sensor follow local regulations regarding disposal of hospital waste ...

Page 32: ...6 4 FOR YOUR NOTES ...

Page 33: ... in your PC Take Windows 2000 for example you can follow the steps below for installation 1 Insert the installation CD into the CD ROM 2 Run the file Setup exe in the installation CD 3 Choose your favorite language according to the prompt Click OK and then click Next in the next dialog box 4 Input the correct serial number and click Next to resume 5 Select the serial port to connect DPM1 Pulse Oxi...

Page 34: ...t System and click the Change Remove button Then following the prompt to uninstall the PMS software NOTE z The steps above are provided as examples only They maybe a bit different from your operation if you use other operation system 7 2 Main Interface Double clicking the shortcut icon for PMS software on the desktop of your computer the Main Interface of PMS software will be displayed Figure 7 1 ...

Page 35: ... preview the data to be printed Print Setting Click to open the Print Setting dialog box Exit Click to exit the PMS software Setup Click the Setup menu to see its pull down menu as shown below Figure 7 3 There are two submenus Patient Information Click to open the Modify Patient Information dialog box Serial Port Selection Click to open the Serial Port Selection dialog box When you use the Data Ou...

Page 36: ...you open the Help document if a dialog box pops up and informs you to install language pack please select Never install any language packs and then click Cancel button 7 2 2 Tool Bar In the tool bar you can see the following shortcut icons Table 7 1 Shortcut Icons Icon Icon Name Description File Management Equals to File Management submenu Print Equals to Print submenu Print Preview Equals to Prin...

Page 37: ... the shortcut icon NOTE z The data displayed as is invalid z The ADD appearing beside the check record number is to indicate that the data thereafter are additional ones to this ID 7 3 Functions Before operate the function hereinafter please first connect DPM1 with your PC Refer to 3 5 Connect Computer and then double click the shortcut icon on the desktop to run the PMS software 7 3 1 Data Output...

Page 38: ...ormation and data outputted from DPM1 will be displayed in the Data Area 5 If error occurs during outputting the following prompt will pop up Figure 7 8 When this situation occurs please check whether the serial port is correctly connected and try to select another serial port by clicking the Serial Port Selection menu 7 3 2 Software Upgrade With the PMS software you can upgrade the internal softw...

Page 39: ...system will check the validity and verify version of the Upgrade File If the Upgrade File is valid and the current version loaded on the DPM1 Pulse Oximeter is lower than the Upgrade file the following message will be displayed Figure 7 12 6 Click Yes and the system will start to upgrade the software automatically If you click Cancel when the upgrading is in process the software in the DPM1 will b...

Page 40: ...outputted conveniently 1 Click File Management from the File menu the File Management dialog box will pop up as shown below Figure 7 16 2 You can choose the folder where the outputted data is saved in the File List The Files contained in that folder will be displayed in the right 3 To open a file choose a file name and click Open button and then the data contained in the file will be displayed in ...

Page 41: ...to 65535 Patient No 12 characters English Character or number at maximum Doctor Name of the doctor 30characters at maximum 3 Click OK the dialog box will disappear and the information inputted will be displayed in the Information Area 4 Click Cancel the dialog box disappears and no information listed above will be modified 7 3 5 Print Data 1 Click Print Setting from the File menu to display the di...

Page 42: ...d Error The password inputted is incorrect Input the correct password or exit the upgrade operation Serial Port Error Other program is using the serial port selected Choose another serial port or close the program that using the selected serial port Age Input Error The age inputted is out of the range 1 255 Input the age again Bed No Input Error The No inputted is out of the range 1 65535 Input th...

Page 43: ...ult Disposable 520A 30 64101 520P Single patient SpO2 Sensor Pediatric Disposable 520P 30 64201 520I Single patient SpO2 Sensor Infant Disposable 520I 30 64301 512E Adult SpO2 Sensor Reusable 512E 30 90390 512F Adult SpO2 Sensor Reusable 512F 30 28263 512G Pediatric SpO2 Sensor Reusable 512G 30 90607 512H Pediatric SpO2 Sensor Reusable 512H 30 79061 518B Multisite SpO2 Sensor Reusable 518B 30 7210...

Page 44: ...8 2 FOR YOUR NOTES ...

Page 45: ...ifications are applicable to the DPM1 Pulse Oximeter with sensors listed in chapter 8 Accessories 2 1 SpO2 Range 0 to 100 Resolution 1 Accuracy 70 to 100 2 Adult Pediatric 70 to 100 3 Neonate 0 to 69 Unspecified Studies were performed to validate the accuracy of Pulse Oximeter with neonatal SpO2 sensors by contrast with a CO Oximeter Some neonates aged from 1 day to 30 days with a gestation age of...

Page 46: ...yed and the power off has a 2 second delay Backlight button Switches on off the backlight ID Confirm button Confirms whether use the previous ID for the new measurement Backlight button ID Confirm button Deletes data 3 3 Power Saving Features Refer to 5 3 Power Management 3 4 Connector One dual purpose socket for connecting SpO2 sensor and communication cable 4 Electrical specifications Working Vo...

Page 47: ...A transportation test procedure 7 5 Shock Meets all the specifications after being exposed a half sinusoidal pulse that is 15g and 11ms as required by IEC 68 2 27 7 6 Vibration After being subjected to sinusoidal or random vibration see FDA Reviewer Guidance for Pre market Notification Submission November 1993 draft the oximeter meets all the specifications Sinusoidal vibration As required by IEC ...

Page 48: ...er 1993 paragraph i7 Mechanical stability Meets the requirements of IEC 60601 1 clause 24 1 Incompatibility with external connectors Meets the requirements of IEC 60601 1 clause 56 3 and of FDA Reviewer Guidance for Premarket Notification Submission November1993 i2 Enclosure rigidity and strength Meets the requirements of IEC 60601 1 clause 21a 16a and 21b Meets the requirements of UL 2601 1 claus...

Page 49: ... customer or the user of the equipment should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance RF Emissions CISPR 11 Group 1 The equipment 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 ...

Page 50: ...t 8 kV air 6 kV contact 8 kV 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 IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips Short interruptions and voltage variation on power supply input lines IEC 61000 4 11 Not applicable the equipment is powered by internal battery Power ...

Page 51: ...nce calculated from the equation applicable to the frequency of the transmitter Recommended separation distance P 2 1 d P 2 1 d 80 MHz to 800 MHz P 3 2 d 800 MHz to 2 5 GHz 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 meters m Field strengths from fixed RF transmitters as determine...

Page 52: ...bance are controlled The customer or the user of the equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment transmitters and the equipment as recommended below according to the maximum output power of the communication equipment Separation Distance According to Frequency of Transmitter M Meters Rated Maximum ...

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