DPM 1 Pulse Oximeter Operators Manual Rev 3.0 April 2010

Manufacturer’s Responsibility All information contained in this manual is believed to be correct. Mindray DS shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing or use of this manual. Mindray will not be liable for the effects on safety, reliability and performance of this product if: „

any installation operations, expansions, changes, modifications and repairs of this product are not conducted by Mindray DS authorized personnel; and

„

the electrical installation of the relevant room does not comply with the applicable national and local requirements; and

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the product is not used in accordance with 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 from the improper use or application of the product or the use of parts or accessories not approved by Mindray DS or repairs by people other than Mindray DS authorized personnel. This warranty shall not extend to „

Any Mindray DS product which has been subjected to misuse, negligence or accident; or

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Any Mindray DS product from which Mindray DS's original serial number tag or product identification markings have been altered or removed; or

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Any product of any other manufacturer.

II

Return Policy In the event that it becomes necessary to return a unit to Mindray DS, follow the instructions below. 1. Return authorization. Contact the Customer Service Department and obtain a Customer Service Authorization number. This number must appear on the outside of the shipping container. Returned shipments will not be accepted if the 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 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 Information Manufacturer:

Mindray DS USA, Inc.

Address:

800 MacArthur Blvd.Mahwah, New Jersey 07430 USA

Tel:

1.800.288.2121,

Website:

www.mindray.com

1.201.995.8000

III

Preface Manual Purpose This manual provides the instructions necessary to operate DPM1 Pulse Oximeter (hereinafter called as DPM1) in accordance with its function and intended use. Observance of this manual is a prerequisite for proper performance and correct operation, and ensures patient and operator safety. This manual is an integral part of and should always be kept close to the your DPM1, so that it can be obtained conveniently when necessary.

Intended Audience This manual is geared for the clinical medical professionals. Clinical medical professionals are expected to have working knowledge of medical procedures, practices and terminology as required for 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 are provided as examples only. They may not necessarily accord with the graph, settings or data displayed on your DPM1. All names appeared in this manual and illustrations are fictive. It is a mere coincidence if the name is the same with yours.

Conventions „

Italic text is used in this manual to quote the referenced chapters or sections.

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The terms warning, and caution are used throughout this manual to point out hazards and to designate a degree or level or seriousness. IV

Contents 1 Safety ... 1-1 1.1 Safety Information ... 1-1 1.1.1 Warnings... 1-2 1.1.2 Cautions ... 1-3 1.1.3 Notes ... 1-3 1.2 Equipment Symbols ... 1-4 2 General... 2-1 2.1 Introduction... 2-1 2.2 Contraindications ... 2-1 2.3 Functions... 2-1 2.4 Appearance... 2-2 2.5 Displayed Information ... 2-2 2.6 Button Operation... 2-3 2.6.1 Power Button... 2-3 2.6.2 Backlight 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 ... 4-3 4.4 Measuring Limitations ... 4-4 5 Other Functions... 5-1 5.1 Data Management ... 5-1 5.1.1 Data Storage ... 5-1 5.1.2 Data Adding ... 5-2 1

5.1.3 Data Protection... 5-2 5.1.4 Data Deletion ... 5-2 5.2 Messages Prompting ... 5-3 5.3 Power Management... 5-4 5.3.1 Battery Detection ... 5-4 5.3.2 Energy Saving ... 5-4 6 Maintenance ... 6-1 6.1 System Check... 6-1 6.2 Cleaning ... 6-1 6.3 Disinfection... 6-2 6.4 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 Accessories ... 8-1 A Specifications ... A-1 B EMC...B-1

2

1 Safety 1.1 Safety Information The safety statements presented in this chapter refer to the basic safety information that the operator of DPM1 shall pay attention to and abide by. There are additional safety statements in other chapters or sections, 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 information to ensure that you get the most from your product.

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1.1.1 Warnings

WARNING z

DPM1 is intended for use by qualified clinical physicians or well-trained nurses in hospital.

z

DPM1 is designed for real-time and rapid measurement of the patient’s SpO2. It is not suitable for long-time continuous patient monitoring. Continual measurement must not exceed 2 hours.

z

DPM1 is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. It is not intended as a device used for treatment purposes.

z

To ensure patient safety, verify this device and accessories can function safely and normally before use.

z

EXPLOSION HAZARD: Do not use DPM1 in the presence of flammable anesthetics, explosive substances, vapors or liquids.

z

Failure to implement a satisfactory maintenance 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 the proper performance of DPM1. For this reason make sure that all external devices operated in the vicinity of DPM1 comply with the relevant EMC requirements. Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.

z

DPM1 and its accessories may be contaminated by microorganism during transporting, use and storage. Use the recommended methods to sterilize and disinfect DPM1 or its accessories when the packing material is damaged, or it has not been used for a long time.

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1.1.2 Cautions

CAUTION z

Federal Law (USA) restricts this device to sale by or on the order of a physician.

z

The device should be appropriately placed. Keep it from falling, strong vibration or other mechanical damage.

z

To ensure patient safety, use only parts and accessories specified 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 manual, all safety information and specifications.

z

This device is not intended for home use.

1-3

1.2 Equipment Symbols Attention! Consult accompanying documents (this manual). Type BF applied part according to IEC 60601-1. This symbol indicates the socket can connect with the PC through a communication cable. 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. Medical equipment with respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1, CAN/CSA C22.2 NO.601-1.

1-4

2 General 2.1 Introduction DPM1 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using specified sensors labeled for patients ranging from neonates to adults. Parameters measured by DPM1 include: arterial oxygen saturation (SpO2), pulse rate (PR) and pulse strength. DPM1 measures these parameters through a SpO2 sensor and displays them on the LCD screen after certain further processing. DPM1 is operated and controlled by three buttons, which are Power button, Backlight button 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.

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Prompting: Memory full, ID full, low battery, standby, and technical error etc.

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Power managing: automatic standby, automatic shutdown.

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Data Managing: data storage, data protection, data deletion.

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Data Printing: patient information and trend data.

For the data printing function, you must install the Pulse Oximeter management system in a PC equipped with a printer, and connect DPM1 with the PC by a communication cable. For details, please refer to the 7Pulse Oximeter Management System

2-1

2.4 Appearance 1

2

3 4 5 6 7 8 Figure 2-1 Front Panel

Figure 2-2 Back Panel

Table 2-1 Appearance description No.

Description

Remarks

1

Dual-purpose socket

It connects SpO2 sensor or PC communication cable.

2

LCD

It displays information listed in Table 2-2.

3

Power

It turns 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 8

Caution. Refer to this manual. Battery door

Open it to install or remove batteries.

2.5 Displayed Information The figure below shows information displayed on DPM1’s screen. 1 2

5

3 6

4

7 Figure 2-3 Displayed Information Table 2-2 Description of displayed information 2-2

No.

Description

Remarks

1

ID number

It displays current ID number ranging from 000 to 100

2

ID Full

It appears when ID≥95 and blinks when stored ID is being covered by new ID.

3

Memory Full

It appears when previous data is to be covered by new data. Please refer to 5.1.1 Data Storage.

4

Pulse Strength

It can display 7 segments at most to indicate real time pulse strength.

5

SpO2 value

It displays SpO2 value and is refreshed every second.

6

PR value

It displays PR value and is refreshed every second. Unit: bpm (beats/minute)

7

Low battery

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.

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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 Batteries.

z

In case the SpO2 cable becomes disconnected or the finger moves away from the sensor, DPM1 will automatically enter the standby mode. Under this mode, when a finger is inserted into the sensor, DPM1 will automatically resume the operation mode. Otherwise, if no finger is inserted in 5 minutes, DPM1 will automatically shut down.

2-3

2.6.2 Backlight Button „

Backlight on: Press the Backlight button to turn on backlight.

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Backlight off: Press the Backlight button to turn off backlight.

2.6.3 Confirm ID Button The Confirm ID button is used 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 button.

2-4

3 Installation 3.1 Unpacking and Inspection Before unpacking, examine the packing case carefully for signs of damage. If any damage is detected, contact the carrier or our company. If the packing case is intact, open the package and remove the instrument and accessories carefully. Check all materials against the packing list and check for any mechanical damage. Contact our Customer Service Department for in case 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.

Place the other hand on the battery cover.

3.

Push the cover away as Figure 3-1 shows.

4.

Place batteries into the slots per the “+” and “-” indications as shown in Figure 3-2.

5.

Push back the battery cover.

Figure 3-1

Figure 3-2 3-1

CAUTION z

To dispose of the batteries, follow local laws for proper disposal.

z

Use AA alkaline batteries or rechargeable batteries. Do not use carbon or poor quality batteries. Remove the batteries if the device is not to be used for a long time.

z

During use, replace batteries of insufficient energy in time with good ones; abnormal power supply may lead to product damages 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 Connect SpO2 Sensor As show below, you can connect the SpO2 sensor to DPM1 by simply inserting the sensor’s connector to DPM1’s dual-purpose socket.

Figure 3-5 Connect SpO2 sensor

3-2

3.5 Connect Computer DPM1 can be connected to a Personal Computer through a communication cable 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.

3-3

FOR YOUR NOTES

3-4

4 Measurement 4.1 Measuring Principle SpO2 monitoring is a non-invasive technique used to measure the amount of oxygenated haemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The light generated in the probe passes through the tissue and is converted into electrical signals by the photodetector in the probe. The DPM1 processes the electrical signal and displays on the screen digital values for SpO2 and pulse rate. The displayed SpO2 value is of functional saturation. The sensor measurement wavelengths are nominally 660nm for the red LED and 940nm for infrared LED. The maximum optical power output for LED is 4mW.

4.2 Precautions NOTE z

Do not perform SpO2 monitoring and NIBP measurements 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 SpO2 sensor once the package or the sensor is found damaged.

z

Don’t use DPM1 to measure patients whose pulse rate is lower than 25bpm, which may cause incorrect results.

z

Remove the SpO2 sensor from the patient after measurement.

z

As with any medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. Cables of electrical surgical equipment should not be winded around that of the SpO2 sensor.

z

Do not put the sensor on extremities with arterial catheter or venous syringe. 4-1

WARNING z

If no pulse is found or the reading is unreasonable, first check the patient’s condition, and then check the device and the SpO2 sensor for proper functions.

z

Do not reuse disposable SpO2 sensors.

z

Make sure no contamination or scar exists in the site where the sensor is placed. Otherwise, the measured result may be incorrect because the signal received by the sensor is affected.

z

When used on different patients, DPM1 is prone to crossed contamination, which should be prevented and controlled by the user. Disinfection is recommended before using the SpO2 sensor on other patients.

4.3 Measuring Steps Sensor selection for SpO2 measurement 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 appropriate site on the patient.

Figure 4-1 placing the adult SpO2 sensor 4.

The readings will be displayed on DPM1’s LCD screen a moment later.

NOTE z

Place the SpO2 sensor cable at the backside of the patient hand. Make sure the fingernail is just opposite to the light emitted from the sensor.

z

To acquire accurate results, please read data until the sensor is steadily placed.

z

Readings may not be accurate when either the sensor or the patient is moving.

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