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Table of Contents
Summary of Contents for TempIR Angel Heart
- Page 1 ANGEL HEART FETAL DOPPLER User Manual...
- Page 3 Attention This user manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices and harmonized standards. In case of modifications and software upgrades, the information contained in this document is subject to change without notice. The manufacturer makes no warranty of any kind with regard to this material, including, but not limited to the implied warranties of merchantability and fitness for a particular purpose.
- Page 4 WARNING : A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION : A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. Note: A NOTE provides useful information regarding a function or procedure.
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Page 5: Table Of Contents
6.3 Disinfecting ................22 Chapter7 Solutions for possible problems........23 Appendix 1 ................... 24 Appendix 2 ................... 25 Appendix 3 ................... 30 Please note: The TempIR Fetal Doppler is not a medical device. If you have any concerns contact your local doctor. -
Page 6: Chapter 1 Safety Guidance
Chapter 1 Safety Guidance This unit is internally powered equipment; the degree of shock protection is type B applied part. Type B applied part protection means that these patient connections will comply with permitted leakage currents, dielectric strengths of IEC 60601-1. 1.1 Safety Precautions WARNING and CAUTION messages must be observed. - Page 7 Furthermore all configurations shall comply with the valid version of the system standard IEC60601-1-1. Everybody who connects additional equipment to the signal input connector or signal output connector configures a medical system, and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC 60601-1-1.
- Page 8 CAUTION : Do not use high temperature sterilizing process and E-beam or gamma radiation sterilization. CAUTION : Electromagnetic Interference-Ensure that the environment in which the device is operated is not subject to any sources of strong electromagnetic interference, such as radio transmitters, mobile telephones, etc. Keep them far away.
- Page 9 CAUTION : The battery must be properly disposed according to local regulation after their use. CAUTION : The battery must be taken out from the battery compartment if the device will not be used for a long time. CAUTION : The device shall only be used if the battery cover is closed. CAUTION : Battery must be stored in cool and dry place.
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Page 10: Chapter 2 Introduction
without strong electromagnetic field, which may influence measure result. When cleaning the machine: CAUTION : Don’t use strong solvent, for example, acetone. CAUTION : Never use an abrasive such as steel wool or metal polish. CAUTION : Do not allow any liquid to enter the product, and do not immerse any parts of the device into any liquids. -
Page 11: Features
averaged FHR display mode, and manual mode. All three models have audio output, and can be connected with earphone or recorder with audio input. It uses standard 1.5 V DC alkaline batteries (2 pieces). 2.2 Features Battery status indicator low power inspection of the battery Built-in speaker Output for headphones The probe can be changeable... -
Page 12: Front Panel
Battery Compartment Fig. 3-2 Rear Panel Headphone Socket Fig.3-3 Top Panel 3.1 Front Panel 3.1.1 Display The LCD display for the Pocket Fetal Doppler is as follows:... -
Page 13: Push Button
Fig.3-4 LCD Display 3.2 Press Button There are three push buttons (POWER, MODE, and BACKLIGHT CONTROL) and a Volume control button on Pocket Fetal Doppler. The primary functions are as follows: 3.2.1 Power Button Function: Power on/off Power on: Press the button once Power off: Press down the button and hold 3 seconds to power off... -
Page 14: Introduction To Top Panel
3.2.2 Mode Button Mode selection button. Function: mode selection, press once to enter next working mode under working status. 3.2.3 Backlight Control Button Function: Under mode 1 and mode 2, press the button to turn on /off backlight. Under mode 3, the button is for start/stop operation, please refer to 4.2.3 manual mode (Mode 3) 3.2.4 Volume Control Indicator Volume adjusting direction indicator. -
Page 15: Chapter 4 General Operation
: The socket, terminal post, or switch that connected with the headphones. : Attention. Refer to the accompanying documents. Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g. IEC 950 for data processing equipment and IEC 60601-1 for medical equipment). -
Page 16: Mode Selection
For the Pocket Fetal Doppler, keep pressing the power button 3 seconds to turn off. CAUTION Put the probe on the best detecting position to get better detecting effect. Don't put the probe on the position where have strong Placental Blood Sound (PBS) or strong Umbilical Sound (UMS). -
Page 17: Probe Operation
4.3 Probe Operation 4.3.1 Inspecting Probe When the probe falls away from the Pocket Fetal Doppler, the LCD screen displays the flickering “— — —”and the probe frequency indication data disappeared. At this moment the probe needs to be reconnected. After connected well, LCD screen will stop flickering and display the probe frequency data. -
Page 18: Inspection Of Low Power
Placing Probe It is opposite to take out probe. Hold the main unit with one hand, and hold the top of the probe with another hand, then push the probe into the probe holder. 4.4 Inspection of low power For the Pocket Fetal Doppler, when it works normally, the LCD screen displays the status of the battery, and the number of the grid in the status represents how much power is left;... -
Page 19: Chapter 5 Product Specification
Chapter 5 Product Specification Product Name: The Pocket Fetal Doppler Safety: Complies with: IEC60601-1 2006 Classification: Anti-electroshock Type: Internally powered equipment. Harmful Liquid Proof Degree: Ordinary equipment (sealed equipment without liquid proof) Degree of Safety in Presence of Flammable Gases: Equipment not suitable for use in presence of flammable gases Working System: Continuous running equipment EMC: Group I Class B... -
Page 20: Chapter 6 Maintenance
Atmospheric Pressure: 50kPa l06kPa Display: 44.5mm×23mm LCD display Backlight: The two statuses can be alternated: turn off/on the backlight. FHR Performance FHR Measuring Range: 50~240BPM (BPM: beat per minute) Resolution: 1BPM Accuracy: ±2BPM Power consumption: <0.8W Auto Shut-OFF: After 1 minute no signal, power off automatically. Battery Type Recommended: Two pieces of 1.5 V DC batteries (SIZE AA LR6). -
Page 21: Cleaning
Gel must be wiped from the probe after use. These precautions will prolong the life of the unit. The user must check that the equipment does not have visible evidence of damage that may affect patient safety or Pocket Fetal Doppler capability before use. -
Page 22: Disinfecting
: Don’t remain any cleaning solution on the surface of the CAUTION device. Notes: Wipe the surface of probe with 70% ethanol, self-air dry, or clean with a clean, dry cloth. 6.3 Disinfecting Clean the equipment case, probe, etc. as above, and then wipe the probe with an alcohol impregnated wipe (70% ethanol). -
Page 23: Chapter7 Solutions For Possible Problems
Chapter7 Solutions for Possible Problems If it appears below problems when you use the Pocket Fetal Doppler, please solve them as below: Problems Possible reasons Solutions volume is too low adjust the volume louder No sound power is low ... -
Page 24: Appendix 1
Appendix 1 Essentiality of Fetal Domestic Monitor Fetal heart rate changes most obviously in the following three periods: 1) Within 30 minutes after pregnant women get up 2) Within 60 minutes after pregnant women finish lunch 3) Within 30 minutes before pregnant women go to bed For the above three periods, because of the change of the body status of pregnant women, the activity of food digesting needs the body to provide more oxygen, relatively, the oxygen for fetus becomes less. -
Page 25: Appendix 2
Appendix 2 Guidance and manufacture’s declaration – electromagnetic emissions- for all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic emission The Pocket Fetal Doppler is intended for use in the electromagnetic environment specified below. The customer of the user of the Pocket Fetal Doppler should assure that it is used in such and environment. - Page 26 Guidance and manufacture’s declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic immunity The Pocket Fetal Doppler is intended for use in the electromagnetic environment specified below. The customer or the user of the Pocket Fetal Doppler should assure that it is used in such an environment.
- Page 27 Guidance and manufacture’s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacture’s declaration – electromagnetic immunity The Pocket Fetal Doppler is intended for use in the electromagnetic environment specified below. The customer or the user of the Pocket Fetal Doppler should assure that it is used in such an environment.
- Page 28 watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:...
- Page 29 Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM – for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the Pocket Fetal Doppler The Pocket Fetal Doppler is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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Page 30: Appendix 3
Appendix 3 Overall Sensitivity... - Page 31 Company Information Website: www.temp-ir.com Email: service@denofgoods.com...