User's Manual

ManualsBrandsContec Medical Systems ManualsElectronicsPulse Oximeter

Instructions to User

Dear users, thank you very much for purchasing the Pulse Oximeter.

This 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 Manual describes, in accordance with the Pulse Oximeter’s features and requirements, main

structure, functions, specifications, correct methods for transportation, installation, usage, operation,

repair, maintenance and storage, etc. As well as the safety procedures to protect both the user and

equipment. Refer to the respective chapters for details.

Please read the User Manual carefully before using this product. The User Manual which describes

the operating procedures should be followed strictly.Failure to follow the User Manual may cause

measuring abnormality, equipment damage and human injury. The manufacturer is NOT responsible

for the safety, reliability and performance issues and any monitoring abnormality, human injury and

equipment damage due to users' negligence of the operation instructions. The manufacturer’s

warranty service does not cover such faults.

Owing to the forthcoming renovation, the specific products you received may not be totally in

accordance with the description of this User Manual. We would sincerely regret for that.

This product is medical device, which can be used repeatedly.

WARNING:

0 Uncomfortable or painful feeling may appear if using the device ceaselessly, especially for

the microcirculation barrier patients. It is recommended that the sensor should not be

applied to the same finger for over 2 hours.

0 For the special patients, there should be a more prudent inspecting in the placing process.

The device can not be clipped on the edema and tender tissue.

0 The light (the infrared is invisible) emitted from the device is harmful to the eyes, so the

user and the maintenance man should not stare at the light.

0 Testee can not use enamel or other makeup.

0 Testee’s fingernail can not be too long.

0 Please refer to the correlative literature about the clinical restrictions and caution.

0 This device is not intended for treatment.

Summary of content (21 pages)

PAGE 1
Instructions to User Dear users, thank you very much for purchasing the Pulse Oximeter. This 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.
PAGE 2
Contents 1. Safety .........................................................................................................................3 1.1. Instructions for safe operations ............................................................................3 1.2. Warning ................................................................................................................3 1.3. Hazards.............................................................................................................
PAGE 3
1. 1.1. Safety Instructions for safe operations Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient’s safety and monitoring performance about cables and transducers. It is recommended that the device should be inspected at least once a week. Please stop using the oximeter if there is obvious damage to the device. Necessary maintenance must be performed by qualified service engineers ONLY.
PAGE 4
0 Please don’t change the battery yourself. 0 The patient is an intended operator. 0 The probe of the device is the applied part. 0 Please don’t use multiple wireless devices connected to the product at the same time. 1.3. Hazards Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture. If the oximeter gets wet, please stop using it immediately.
PAGE 5
the chapter 6.1 as a reference. The device may not work for all patients. If you are unable to achieve stable reading, discontinue use. Do not contort or drag the connection of the device. 1.4. Indication for Use This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: A. This device may not cause harmful interference; B. This device must accept any interference received, including interference that may cause undesired operation.
PAGE 6
2. Overview The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the O2 concentration in the blood. It is an important bio-parameter for the respiration.
PAGE 7
3. Principle Principle of the Oximeter is as follows: An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin (Hb) and Oxyhemoglobin (HbO2) in glow & near-infrared zones.
PAGE 8
4.2. Main Parameters A. Measurement of SpO2 Measurement Range:0%~100％ Accuracy:70~100%,±2%;0~69%,unspecified B. Measurement of pulse rate Measurement Range:30bpm~250bpm Accuracy: ±2 bpm or ±2% (select the larger) C. Resolution SpO2 : 1%, Pulse rate: 1bpm. D. Measurement Performance in Weak Filling Condition: SpO2 and pulse rate can be shown correctly when pulse-filling ratio is 0.4%. SpO2 error is ±4%, pulse rate error is ±2 bpm or ±2% (select the larger). E.
PAGE 9
5. Installation 5.1. View of the front panel Figure 2. Front View 5.2. Installing the hanging rope A. Put the thinner side of the rope through the hole. B. Put the wider side of the rope through the thinner side which has been put through the hole, then tighten it. 5.3. Accessories A. B. C. D. E. F. a hanging rope a user manual a power adapter a data line a disk (PC software) a oximeter probe( optional ) 6. Operating Guide 6.1. Application method 6.1.
PAGE 10
6.1.2 Lay finger The right method of laying finger is as Figure 3 or Figure 4. Figure 3 (Actual probe may be different from the probe as Figure 3, please accept the actual probe with the device) Figure 4 Fingernails and the luminescent tube should be in the same side. If the alarm function is on,the device will provide medium-priority alarm signal when probe or finger is out.Intermittent alarm will occur and the user interface presents "FINGER OUT".
PAGE 11
C If you want to turn off the alarm for good, you should enter the menu for operation. 6.1.5 Menu operations: In the measuring interface,the display direction can be changed by pressing the button with a short push (click). There are four modes of data display that can be viewed. Press the button with a prolonged push (1 second) to enter the Settings Menu Interface (see Figure 5 ).Please Note: When the display direction is lengthways, you can not enter the main menu interface.
PAGE 12
Medium priority indicating that prompt operator response is required. b) The alarm state setting Click the button to select “Alarm”, then press the button to choose alarm on/off. Choose “ on” to turn on the alarms and “ off” to turn off the alarms. Figure 6 Alarm Setting Menu c) Pulse sound indication setting Click the button to select “Pulse Sound”, then press button to choose to have the Pulse Sound (heart beat) “on” or “off”.
PAGE 13
the sign "Recording" would appear on the screen in 30 seconds, then the screen will be automatically shut down. If click the button at this moment, the sign "Recording" would appear on the screen, and then the screen will be automatically shut down again; if press the button,the device would return to the former interface. e) If turning on the data storage function, the former saved data will be automatically deleted.
PAGE 14
in low power status .Intermittent alarm will occur and the battery icon turns red in the state of flashing. High priority indicating that immediate operator response is required. 6.2. Attention for operation A.Please check the device before using, and confirm that it can work normally. B.The finger should be in a proper position (see the attached illustration of Figure 3 and Figure 4 for reference), or else it may result in inaccurate measure. C.
PAGE 15
months when it is no regular used. It can extend the battery life following this guidance. D.Users are advised to calibrate the device termly (or according to the calibrating program of hospital). It also can be performed at the state-appointed agent or just contact us for calibration. 7.3. Transportation and storage A. The packed device can be transported by ordinary conveyance or according to transport contract. The device can not be transported mixed with toxic, harmful, corrosive material. B.
PAGE 16
%SpO2 bpm The pulse oxygen saturation(%) Pulse rate (bpm) Full-voltage Low-voltage Close the alarm sound indication Pause the alarm sound indication Open the alarm sound indication Close the pulse sound indication Open the Wireless indication Open the pulse sound indication menu button/power button/function button USB Type BF SN Serial number 1. The finger clip falls off ( no finger inserted)] 2. Probe error 3.
PAGE 17
Humidity limitation 10. Function Specification Information Display Mode The Pulse Oxygen Saturation(%SpO2) 2-digit digital OLED display Pulse Rate(bpm) 3-digit digital OLED display Pulse Intensity (bar-graph) bar-graph OLED display SpO2 Parameter Specification Measuring range 0%~100% (the resolution is 1%). Accuracy 70%~100%:±2% ,Below 70% unspecified. Average value Calculate the Average value in every 4 measure value. The deviation between average value and true value does not exceed 1%.
PAGE 18
Power Adapter Input Voltage 100 to 240 VAC, 50/60 Hz Output voltage 5 V DC Output current 1000mA Output power 5W Oximeter Probe Wavelength:660nm 880nm Dimensions and Weight Dimensions 57(L) × 32(W) × 32 (H) mm Weight About 50g (with the lithium battery*1) Appendix 1 State Alarm condition delay Alarm signal generation delay Low voltage alarm 1s 20ms SpO2 alarm 330ms 20ms Pulse rate alarm 330ms 20ms Probe error alarm 16ms 20ms Appendix 2 Guidance and manufacturer’s declaration – ele
PAGE 19
RF emission CISPR 11 The CMS50EW is suitable for use in all establishments, including domestic and those directly connected to a low voltage power supply network which supplies buildings used for domestic purposes. Class B Guidance and manufacturer’s declaration – electromagnetic immunity The CMS50EW is intended for use in the electromagnetic environment specified below. The customer or the user of CMS50EW should assure that it is used in such an environment.
PAGE 20
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 metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
PAGE 21
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.