2AC6R-M70CFingertip Pulse Oximeter

Operator’s Manual Fingertip Pulse Oximeter Version number of this manual: V1.1 General Description The measurement of oxygen saturation of arterial blood (also known as pulse oxygen saturation, usually shortened as SpO 2 ) adopts the principles of light spectra and volume tracing. The LED emits lights with two specific wavelengths, which are selectively absorbed by oxygenated hemoglobin and deoxyhemoglobin. The optical receptor measures the changes in the light intensity after the light passes the capillary network and estimates the ratio of oxygenated hemoglobin and the total hemoglobin. The mechanical activity of the heart cause arterial pulse, by measuring the pulse we can get PR value . Precautions For Use
Explosion hazard. Do not use the oximeter in the presence of flammable anesthetics mixture with air, oxygen, or hydrogen.
When the oximeter is in use, there should not be any great power appliances such as high voltage cables, X-ray machine, ultrasound equipment and electrizer in use nearby.
Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.
This oximeter does not have alarm function; please do not use this product in the environment where alarm is required.
The oximeter should be handled with care so as to avoid shocks and falls.
When the oximeter is in use, it must be ensured that the batteries have sufficient capacity; otherwise there might be such phenomena as starting-up abnormalities or inaccurate measurement data, etc.
Please don’t use pointed objects such as pen point or nails to press operation, otherwise it might cause permanent damage to the surface of the keyboard.
Don’t make any clinical judgments based only on the oximeter. The oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms, as well as doctor’s diagnoses.
To ensure accurate performance and prevent device failure, do not expose the oximeter to extreme moisture, such as direct exposure to rain. Such exposure may cause inaccurate performance or device failure.
Do not conduct SpO 2 measurement on the finger smeared with nail polish, otherwise this will lead to unreliable measurement results.
The enclosure shall only be opened by the authorized person.
In order to have more accurate measurements of SpO 2 and PR, the oximeter should be used in quiet and comfortable environment.
Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries.
Prolonged continuous monitoring may increase the risk of unexpected changes in skin characteristics, such as irritation, reddening, blistering or burns. Inspect the sensor site every two hours and move the sensor if the skin quality changes.
Pulse oximeter simulator can not be used to access the accuracy of the pulse oximeter.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference; (2) This device must accept any interference received, including interference that may cause undesired operation. The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment FCC STATEMENT: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: -- Reorient or relocate the receiving antenna. -- Increase the separation between the equipment and receiver. -- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. -- Consult the dealer or an experienced radio/TV technician for help. FCC RADIATION EXPOSURE STATEMENT: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. Intended Use The Fingertip Pulse Oximeter is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult and pediatric patients in hospital, hospital type facilities, as well as in the home care environment. The oximeter is not suitable to monitor patient continuously for long term. Battery Installations 1. Press the button down on the back panel of oximeter and push the battery cover horizontally along the arrow shown as below: 2. Install the batteries into battery cabin in correct polarities. 3. Close the battery cover. Notes:
Put or remove batteries in right order, or it may damage the bracket.
Battery polarities must be correctly installed. Otherwise, damage might be caused to device.
Please remove the battery if the oximeter will not be used for long time. Software Download And Installation 1. Software download methods：
Users who use the ISO system device can log in iphone App Store, enter ”wearcare” and search for the of “SpO2 monitoring software” in the searching results.
Users who use the Android system device can log in the wearcare official website: http://www.wearcare.cn for download. 2. Download SpO2 monitoring software, click installation button for free installation. Operation Instructions 1. Install two AAA batteries…

Text truncated - open the document above for the full version.

External Photos

Internal Photos

SGS-CSTC Standards Technical Services Co., Ltd. Application No..: GZEM1409004600RF Page: 1 of 1 FCC ID: 2AC6R-M70C This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. RF Exposure Compliance Requirement The product belongs to standalone portable device base the FCC rule part 2.1091&2.1093. The transmission frequencies of the device are between 100 MHz and 6 GHz. The worst case test separation distance is 5mm. The Max Conducted Output Power and SAR Test Exclusion Threshold (mW) are listed below: Transmit frequency (GHz) Max Conducted Output Power (mW) SAR Test Exclusion Threshold (mW) 2.402 0.68 9.7 2.442 0.69 9.6 2.480 0.64 9.5 The SAR Test Exclusion Threshold for 100 MHz to 6 GHz is calculated from: 1) The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] · [√f(GHz)] ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremity SAR, where  f(GHz) is the RF channel transmit frequency in GHz  Power and distance are rounded to the nearest mW and mm before calculation The result is rounded to one decimal place for comparison The test exclusions are applicable only when the minimum test separation distance is ≤ 50 mm and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm is applied to determine SAR test exclusion. According to SAR Exclusion Threshold in KDB 447498D01 v05 r02 General RF Exposure Guidance v05, the SAR report is not required.

SGS-CSTC Standards Technical Services Co., Ltd. 198 Kezhu Road, Scientech Park, Guangzhou Economic & Technological Development District, Guangzhou, China 510663 Telephone: +86 (0) 20 82155555 Fax: +86 (0) 20 82075059 Email: [email protected] Report No.: GZEM140900460001 Page: 1 of 53 FCC ID: 2AC6R-M70C Authorized Signature: Jerry Chan Manager The manufacturer should ensure that all products in series production are in conformity with the product sample detailed in this report. If the product in this report is used in any configuration other than that detailed in the report, the manufacturer must ensure the new system complies with all relevant standards. The report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government. All test results in this report can be traceable to National or International Standards. This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only 1 Cover Page TEST REPORT Application No.: GZEM1409004600RF Applicant: Guangdong Biolight Meditech Co.,Ltd. FCC ID: 2AC6R-M70C Product Name: Fingertip Pulse Oximeter Product Description: Bluetooth Electronic Thermometer with 2.4 GHz as carrier Model No.: M70C Trade mark: BLT Standards: CFR 47 FCC PART 15 Subpart C: 2013 section 15.247 Date of Receipt: 2014-09-01 Date of Test: 2014-10-09 to 2014-10-20 Date of Issue: 2014-11-05 Test Result : Pass* * In the configuration tested, the EUT detailed in this report complied with the standards specified above. Please refer to section 3 of this report for further detail. SGS-CSTC Standards Technical Services Co., Ltd. Report No.: GZEM140900460001 Page: 2 of 53 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 2 Version Revision Record Version Chapter Date Modifier Remark 00 2014-11-05 Original Authorized for issue by: Tested By 2014-10-09 to 2014-10-20 (Bill Ma) /Project Engineer Date Prepared By 2014-10-22 (Icy Chen) / Clerk Date Checked By 2014-11-05 (Jerry Chan / Reviewer Date SGS-CSTC Standards Technical Services Co., Ltd. Report No.: GZEM140900460001 Page: 3 of 53 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 3 Test Summary Test Test Requirement Test method Result Antenna Requirement FCC PART 15 C section 15.247 (c) and Section 15.203 FCC PART 15 C section 15.247 (c) and Section 15.203 PASS 6 dB Bandwidth FCC PART 15 C section 15.247 (a)(2) ANSI C63.10: Clause 6.9.1 PASS Maximum Peak Output Power FCC PART 15 C section …

Text truncated - open the document above for the full version.

Test Setup Photos 1.1 RADI ATE D SP URI OU S EM ISSIO N TE ST SETUP Below 1GHz: Above 1GHz: