Copyright Intellectual Property Statement Mindray DS USA, Inc. (hereinafter called Mindray DS) 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 copyright and the patent rights of Mindray DS, nor the rights of others. Mindray DS intends to maintain the contents of this manual as confidential information.
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.
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.
Safety Precautions 1 . Meaning of Signal Words In this manual, the signal words WARNING and CAUTION are used regarding safety and other important instructions. The signal words and their meanings are defined as follows. Please understand their meanings clearly before reading this manual. Signal word Meaning WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
WARNING: Do not connect this system to outlets with the same circuit breakers and fuses that control current to devices such as life-support systems. If this system malfunctions and generates an overcurrent, or when there is an instantaneous current at power ON, the circuit breakers and fuses of the building’s supply circuit may be tripped. Do not use flammable gasses such as anesthetics, or flammable liquids such as ethanol, near this product, because there is danger of explosion. CAUTION: 1.
VI Pulse oximeter Service Manual
Content Content Chapter 1 Introduction...................................................................................................1-1 1.1 General ......................................................................................................................1-1 1.2 Functions....................................................................................................................1-1 1.3 Parameters Measurement.............................................................................
Content 6.3 Disinfection & Sterilization..........................................................................................6-2 6.4 Technical Support.......................................................................................................
Introduction Chapter 1 Introduction 1.1 General The DPM1 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing DPM1 disposable and reusable finger and ear sensors labeled for patients ranging from neonates to adults. Parameters monitored by the DPM1 pulse oximeter include: arterial oxygen saturation (SpO2), pulse rate (PR) and pulse strength.
Introduction For Your Notes 1-2 Pulse oximeter Service Manual
Circuit Principle Chapter 2 Circuit Principle 2.1 Overview The DPM1 pulse oximeter collects SpO2 data from the sensor and sends to mainboard. The maniboard processes the data and displays the results (SpO2 values) on the LCD screen. Pulse-strength bar, battery remained capacity and data export indication are also shown on the screen. DPM1 can be connected with PC through serial port for data transportation and the data can be printed out from PC. 2.1.
Circuit Principle supply for IO module and analog circuit. The voltage of them is 3.3V. S1C33209 has two crystal oscillators, OSC1 and OSC3. OSC1 supplies RTC and system clock frequency, whose frequency is 32.768KHz. OSC3 supplies work frequency to the CPU, whose frequency is 22.1184MHz. 2.1.1.2 Watchdog Circuit The watchdog circuit control chip is MAX823. When S2 is shorted, the program will access watchdog procedure. R64 and C63 compose RC low-pass filter to reduce interference of the reset signal.
Circuit Principle Fig 2-3 Data Storage Circuit 2.1.1.4 DAC DPM1’s analog circuit includes two DAC channels. They are DRIVE channel and OFFSET channel. MAX5102A is a 8-bit resolution DAC control chip. The 2.5V reference level was produced by MAX6066. Fig 2-4 2.1.1.5 DA Circuit ADC DPM1 uses MAX1290 as the ADC, which of 12-bit resolution and 8 channels and parallel interface. Two signals of SIGNAL and PROBE-DET are collected by the chip.
Circuit Principle 2.5V voltage shift should be required. R27-C20, R20-C30 and R23-C19 form RC low pass filters to reduce the interference from high frequency noise. C31 is used to prevent self-oscillating and enhance the reliability. R27 C31 10P R12 100K 1% 9.09K 1% OFFSET C20 1000p R26 9.09K 1% AGND U4B 6 7 R20 5 10K 1% VIN C30 10P LMC6482 R11 100K 1% T51 tp VREF2.
Circuit Principle R85 work together to prevent the locking of the CPU. Fig 2-6 Delay Circuit Block The power-on and power-off signals through two diodes constitute a AND logic output signal named PCON signal, which directly controls the ON/OFF. Resistor R111 is necessary for the AND logic circuit. R95, C82 and E12 form a RC filtering network to protect the circuit from electrostatic charge.
Circuit Principle 2.1.1.8 Serial Port Signal Voltage Level Conversion Circuit MAX202E is used for the signal voltage level conversion. The output of MAX202E is 5V TTL voltage, and the S1C33209’s I/O should use 74HC32 as the voltage level convertor and driver and isolator. R116 and R115 convert the TTL level to LVTTL. R61 and R116 can prevent short-circuit and electrostatic charge damage. Circuit block is shown as below: Fig 2-8 Serial Signal Voltage Level Conversion Circuit 2.1.1.
Circuit Principle 2.1.1.10 Voltage Detect DPM1 requires that the battery voltage and +7V be detected all the time. S1C33209 has 8 10-bit AD channels, two of which were used. S1C33209 cannot stand that high voltage, so, a voltage divider was adopted to convert the monitored voltages to the range S1C33209 can detect. The divided voltage has a RC filter, which can resist the influence from electrostatic charge. 2.1.2 Power Supply Circuit Block Diagram Fig 2-10 Power Supply Circuit Block Diagram 2.
Circuit Principle 2.3 EMC Design The following protections are used for EMC design in DPM1: 1. Every IC has one by-pass capacitor, some ICs have different rating capacitors to enlarge the filter band; 2. Serial resistors on the communication lines connected with the PC, to reduce the interference propagation; 3. RC low pass filter on most low frequency signals, to reduce high frequency interference; 4. One ground plane, no discrimination between digital ground and analog ground; 5.
Specifications Chapter 3 Specifications 3.1. General 3.1.1 Basics Product Model: DPM1 Product Name: Pulse Oximeter IIb (According to MDD 93/42EEC directive) Classification: II (21CFR 870.2700, 870.2710) 3.1.2 Safety Designations Safety designations per IEC 60601-1 Standard: Type of protection against electric Internally powered equipment.
Specifications 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 3.3.3 Power Saving Features The oximeter enters the standby mode if the finger slips off the sensor, or the sensor becomes disconnected from the oximeter.
Specifications 3.7. Physical Characteristics Maximum Size: 65×140×32mm (W×H×D) Maximum Weight: 130g (not include battery and sensor) 3.8.
Specifications Spillage and ingress of liquid: The oximeter meets the requirements of IEC 60601-1-1, clause 44.3 and of IEC 60601-27, clauses 30 and 34. It shall also meet the IEC 529 requirements for IPX0 devices. The oximeter meets the requirements of IEC 60601-1, clauses 42.1， Surface 42.2 and 42.3. temperature: The oximeter meets the requirements of FDA Reviewer Guidance for Premarket Notification Submission, November 1993, paragraph i7.
Structure Chapter 4 Structure 4.
Structure 11 047-000194-00 Equipment label(English) 1 12 0000-10-10902 Battery 4 13 0850-20-30702 Battery cover 1 14 0850-20-30710 Electrode spring - B 1 15 0850-20-30709 Electrode spring - A 2 16 0000-10-11177 NECK STRAP 6 17 0850-20-30707 Cathode contact spring 1 18 0850-20-30706 Anode contact spring 1 4.2 Batteries Installation and Maintenance 4.2.1 Install Batteries The DPM1 pulse oximeter is operated by four 1.5V AA batteries.
Structure 4.2.2 Battery Maintenance 1. Use the generic 1.5V AA alkaline battery or rechargeable battery, and do not use carbon battery or poor quality batteries. Remove the battery when nonuse for long time. 2. Replace the battery when the battery charge is insufficient for operation; abnormal power supply may lead to equipment damage or even personal injuries. Notes： 1. The low battery symbol appears when the battery voltage is lower than 4.0V; 2.
Structure FOR YOUR NOTES Pulse oximeter Service Manual 4-4
Test and Prompt List Chapter 5 Test and Prompt List 5.1 Test Procedure 5.1.1 Connection Install batteries and connect a simulator with the DPM1. Turn on the power. LCD will display startup image and then the DPM1 enters the normal working mode. 5.1.2 Button Function Test Press all the buttons one by one to inspect if the expected operation is executed promptly. 5.1.3 SpO2 Measurement Test ID number display test: turn on the power and the ID number should blink for a few seconds.
Test and Prompt List 5.2 Prompt List Table 5-1 Prompt Information on LCD Indications Cause Low The battery Solution battery voltage is symbol below the threshold value Memory full Available symbol locations ＜10 Memory full symbol blinks ID full symbol ID full symbol blinks Standby symbol Communication symbol DELETE ALL? ALL DELETED data memory Replace the battery The existing data will be overwritten. Export the data in time. The existing data has been overwritten.
Maintenance and Cleaning Chapter 6 Maintenance and Cleaning 6.1 Maintenance 6.1.1 Unpacking and Inspection 1. Inspect the DPM1 for possible damage during shipment; 2. Check all the cables joint part and accessories; 3. Test all the functions applicable to the patients and assure the DPM1 in right states.
Maintenance and Cleaning 5. Keep the surface of the equipment clean after cleaning. Detergents 1. Diluted ammonia. 2. Diluted sodium hypochlorite（bleaching powder for washing）。 3. Diluted formaldehyde 35～37%. 4. Hydrogen peroxide 3%. 5. Ethanol. 6. Isopropano. 6.3 Disinfection & Sterilization Disinfection: Disinfection may damage the equipment, so, it is not advised to do unless necessary in the hospital’s maintenance plan. Cleaning is recommended before disinfection.
P/N: 046-000175-00 (3.
