iPulseOX SMPO1000-US CareSimple User Manual

User Manual
Pulse Oximeter SMPO1000-US Manufactured far Smart Meter Corporation
201 IE. 1pnnetfy
‘Yampa, Flimflam 33602
Release date: 12/01/2021 Version: 1.0

Product Description

A Pulse Oximeter is an important and common device used to check oxygen saturation (Sp02) and pulse rate (PR). It is a small, compact, simple, reliable and durable  physiological monito ring device. This device contains the mainboard, OLED display and dry batteries.

Intended Use

The pulse oximeter is a reusable device, and is intended for intermittent checks of oxygen saturation and pulse rate of adults at home or in a clinical environment. This  medical d evice is not intended for continuous monitoring.
Applicable people and scope
The pulse oximeter is intended for monitoring adults. It may be used at ho me or in c linic settings.
Contraindications
T he pulse oximeter should not be used to monitor children . It is not suitabl e for u se on injured skin tissue.

Safety Information

• Read Instructions for use prior to using your impulsion.
• The pulse oximeter r is only m east to a assess patio nets’ physiological conditions.
• EXPLOSION HAZARD: Do not use the pulse oximeter in the prese-nice or flammable anesthetics, explain substances, Yap ores or liq1lids.
• Modification of the pulse oximeter is not recommended. Any product maintenance should be done by manufacturer-approved, professional maintenance pe1-sonneL
• Please shut off the power before dealing the pulse oximeter: Disinfecting the pulse oximeter via high-pressure and high-temperature methods is prohibited. Any cleaning  agents/disinfectants other than recommended ones listed in the operation manual are not recommended for use.
• T he pulse oximeter is not waterproof. Keep its surface dry and clean.
• Avoid any pressure, jostling, strong vi rations, or other potential mechanical damage. Hold it carefully and lightly. If it is not in use, t he pulse oximeter should be  appropriately stored.
• Use AAA alkaline batte1i es.
• \Vhen possible keep the pulse oximeter away from a ny radio receivers when in use.

Product Feature

1. Simple and convenient operation with one button.
2. Compact, lightweight, and convenient to cany.
3. B attery indicator on screen.
4. Will automatically tum off after 10 seconds when there’s no signal.
5. Device data can be record in an EMR via cellular commwtication.

Display Introduction

Battery Installation

1. Open the battery compartment as shown in fi gure 2.
2. Install batteries into the slots according to the “+” and ” -” symbols as shown in Figure 3. C over the lid onto the battery compartment and push it upwards to make it  close.
   • T he positive a nd negative ends of batte1ies must be installed correctly, otherwise the d evice will not work.
   • \Vhen installing or removing batteries, ple as e follow the correct procedure, to a\’oid battery compartment may be damaged.

Lanyard Installation

1. Thread the thinner end of the lanyard through the lanyard hole. The position of the lanyard hole is shown in Figure 4. (Notice: the lanyard hole is on both sides.)
2. Thread the thicker end o f the lanyard through the thinner end of the lanyard. Then, pull the thicker end of the lanyard until it’s tight.

Directions for use

1. After properly installing two AAA batteries, press lid as shown in the F inure 5 and open the clip. Position finger into the rubber cushions of the clip, make sure the  finger is in the right position as shown in Figure 5, and then release the clip to close over the fi nder.
2. Press the white button and tum on the device. Wait for a moment, the sp02 value and PR value w ill be displayed on the OLED screen after wave and measured values are stable, as shown in Figu re 6.
3. Be sure to place the patient’s finger inside the product in the correct orientation. The LED part of the sensor should be at the backside of the patient hand. Be sure to  insert the finger deep enough into the sensor so that the fingernail is opposite to the light emitted from the sensor.
4. Don’ t move the fin germ and remain motionless doming the  process.
5. Data update pe1·iod is less than 30 seconds.

NOTE:

• C heck the pulse oximeter for damage before use. If it’s damaged, don’ t use it.
• Don’t put the pulse oximeter on extremities with a r trial catheter o r venous syringe.
• Don’t perform SpO2 and NIBP mesa remints on the same arm simultaneously.
• Obstruction of blood flow doming NIBP measure mints may adnrsely affect the reading or the SpO2 value.
• Don’t use the pulse oximeter to measure patients w hose p use rates are lower that n 30bpm (this may cause incur recto results).
• The well perfusion of mean Suring instrument should fully cover the test window of the sensor. Clearn and d ray the measurement part before storing the pulse oximeters.
• Con the sensor \\”ith opaque matter al under sh·tmg light. Othen,ise, the light can clause inaccurate measure mints.
• Make sure that the.re is 110 contamination or scarring on t he tested finge1·. Otherwise, the results may be icon act .
• The device is intended-d for single patient use.
• Incorrect placemen t or the sensor may affect the accuracy or the measurements. The same horizontal position parallel with heart sho uld be chosen to achieve the best  measurements.
• The highest temperature of us age s hold’s exceed 4 1°C (105 Fahrenheit).

Factors affecting measurement occur a cy:

• The measurements depend on absorb tion of pedal wavelength ray bye oxidized hemoglobin and deoxyhemoglobin. The concentration of non-functional he  myoglobin may affect the accuracy or the measurement.
• Shock, a n email, up oath u main, and vasoconstrictive drugs may decrease a rte. rail blood now to all allmeasurable lent.
• P pigments or deep colors (i.e. nail polish, artificial nails, d yes, or pigmented cream) may cause inaccurate measurement ts.

Data Communication Function Description
a. Once the data has been displayed on the screen. the cellular data transfer will begin automatically. Uploading will appear on the screen (as shown in Figure 7).
b. The SPO> reading. and the PR will be uploaded in the patient record associated with the device serial number. Once the data has been transferred the screen will display a  message “Goodbye”. (as shown in Figure 10).
The device will automatically be powered off after a few seconds. d. When the received signal is inadequacy, will be  displayed on the screen. (as shown in Figure 9)
e. Once the data has been displayed on the screen, pressing the “POWER/ FUNCTION” button one time, the display direction will be rotated. (as shown in Finger 8)

Cleaning and Disinfection

Do not immerse the device or any relevant accessories in water or disinfectant.

1. Clean the product with cotton or soft cloth lightly moistened with water.
2. After cleaning, dry with a soft cloth or allow the device to dry naturally.

Disinfection
The recommended disinfectants include: ethanol 70%, isopropanol 70%, g glutaraldehyde (2%) solution disinfectants.

1. Clean the product as instmcted above.
2. is infect the product with cotton or soft cloth moistened with one of the recommended disinfectants.
3.  After disinfection, wipe off the device with a soft cloth moistened with water.
4. Leave the device to dry naturally.

Packing List

The standard configuration

Pulse Oximeter| 1pc
Zipper case| 1pc
Lanyard| 1pc
The operation manual| 1pc
AAA Alkaline batteries| 2 pcs

Expected service life: 3 years

Technical Specifications

1. Diale mode: OLEO

2. Spot,:
   Measurement range: 0~100%
   Accuracy: ±3% (70%- 100%)

3. Pulse Rate:
   Measurement range: 25~250bpm
   Accuracy: ±2bpm
   • Pulse Rate accuracy bas passed the verification and com parson with SpO1 simulator.

4. Low perfusion :
   Range: 0.5%~20%
   SpO2 accuracy: ±3% (70%~100%)
   PR accuracy: 25~250bpm, ±2bpm

5. Electric.al specifications:
   Working voltage: D.C.2.2 V~D.C.3.4V
   Battery Type: Two 1.5V AAA alkaline batteries
   Power consumption: smaller than S0mA

6. Product specifications:
   Size: 58 (H) x 34 (W) x 30(D) I’ll
   Weight: 50g (include two AAA batteries)

7. Environment requirements:
   Temperature:
   Operation: +5~+40°C
   Transport and storage: -10-+S0°C
   Humidity:
   Operation: 15%-S0o/o(noncondensing)
   Transport and storage: 1 Q% …. 90%(noncondensing) Atmospheric pressure:
   Operation: 860hPa~ 1060hPa
   Transport and storage: 700h.Pa~l060hPa
   NOTE:
   Wavelength: 6661ml/905nm Output power: <0. l mW

Arms Specifications
l. SpO2Amis:

2. Clinical Data Graphical Plot:

Hem oximeter Range| 60—80| 80- 100| 60–100| 70-100| 60- 70| 70—80| 80- 90| 90–100
---|---|---|---|---|---|---|---|---
Mean| 0.27| 0.74| 0 .58| 0.57| 0.9| 0.25| 1| 0 .12
count| 102| 185| 287| 284| 3| 99| 131| 54
Missing Data| 0| 2| 2| 2| 0| 0| 0| 2
Standard Deviation| 1.64| 1.25| 1.42| 1.42| 1_23| 1.65| 1.65| 1.11
Standard Error| 0_16| 0.09| 0 .08| 0.08| 0 _71| 0.17| 0.17| 0 .15
95%Conlideocelnterval| 0.32| 0.1 8| 0 .16| 0.17| 1_39| 0.33| 0.33| 0 .30
Upper LOA| 3.55| 3.22| 3.38| 3.38| N/A| 3.55| 3.55| 2 .29
LowerLOA| -3.01| -1.73| -2.23| -2.24| N/A| -3.05| -3.05| -2.05
Maximum| 4.5| 5.2| 5.2| 5.2| 1_80| 4.5| 4.5| 2.4
Minimum| -5.2| -3.1| -5.2| -5.2| -0.5| -5.2| -5.2| -3.1
Root Mean Square| 1.66| 1.45| 1.53| 1.53| 1_35| 1.67| 1.67| 1.11

Troubleshooting

finger is not properly positioned.
2.The patient’s Sp02 is too low to be detected.| 1.Please try again.
2.Try again; Go to a hospital for a diagnosis if you are sure the device works all right.
The Sp02 and PR display unstable.| 1.The finger is not placed inside enough.
2.The finger is shaking or the testee is moving.| 1.Place the finger properly and try again.
2.Relax
The device can’t be powered on.| 1.The batteries are drained or almost drained.
2.The installation of batteries is not correct.
3.The device’s malfunction.| 1.Change batteries.
2.Reinstall batteries.
3.Call Customer Service at 1-844-445-8267
The screen is suddenly off.| 1.The product is automatically powered off when no signal is detected longer than 10 seconds.
2.Power of the batteries is exhausted.| 1.Normal.
2.Replace the batteries.

Symbol Meaning

separate collection facilities for recovery and recycling.
| Information of manufacture, including name and address.
| Date of manufacture.
| Serial Number.
| Batch Code.
| Type Number.
| Degrees of protection provided by enclosure.

Manufactured for Smart Meter Corporation by:
Shanghai Berry Electronic Tech Co., Ltd.
Unit 104, iF loor, 7 Building, No.1188 Lianhang Road,
Minhang District, Shanghai, China 201112
TEL: +86-21-5853 1958 FAX: +86-21-5853 0420
WEB: www.shberrymed.com
If you need additional information, please contact customer service at 1-844-445-8267.

Appendix A EMC Declaration
Guidance and manufacturer’s declaration – electromagnetic emissions – for all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic emission

This Pulse Oximeter is intended for use in the electromagnetic environment sheaf. below. The customer or the user of this Pulse Oximeter shoo. assure that it is used in such an environment
Emission Test| Compliance| Electromagnetic Environment-Guidance
RF emissions CISPR 11| Gump 1| This Pulse Oximeter uses RF energy only for rots internal function Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CIS,11| Class B| This Pulse Oximeter is suitable for use in all establishments, including domestic establishment and those directly connected to a low voltage power supply network which supplies buildings us. for domestic purposes.

Guidance and manufacturer’s decal redon – electromagnetic immunity – for all EQUIPMENT a nd SYSTEMS

Guidance and manufacturer’s declaration-electromagnetic immunity

This Pulse Oximeter is intend. for use in the electromagnetic environment specific. below. The customer or the user of this Pulse Oximeter should assure that it is used in such an environment.
Immunity Test| IEC 60601 Test Level| Compliance Level| Elect. Zwnment
ELECTROSTATIC DISCHARGE., IEC 610004-2| ±8 KV contact ±2 KV, . KV, ±8 KV, ±15 KV air| .±8 Kev coot, ±2 IN, ±4 KV, ±8 KV, ±15 KV air| Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the
relative humidity should be at
least 30%.
RATED power frequency magnetic fields bi.
IEC 6.0-4-8| 30A/m5
50 Hz or 60 Hz| 30A/m d/| Mass power quality should be Mat of a typical commercial or hospital environment.
a, Discharges shall be applied with no connection to an artificial hand a. no connection to PATIENT simulation. PATIENT simulation may be connected after the test as needed in order to verify BASIC SAFETY and ESSENTIAL PERFORMANCE.
bl Applies only to ME EQUIPMENT and ME SYSTEMS with magnetically sensitive components or circuitry. ., During the test. the ME EQUIPMENT or ME SYSTEMS may be powered at any NOMINAL input voltage, but with the same frequency as the test signal (see Table 1).
dl This test level assumes a minimum distance between the ME EQUIPMENT cr ME SYSTEMS and sources of power frequency magnetic field of at least 15 crn. If the RISK ANALYSIS shows Mat Me ME EQUIPMENT or ME SYSTEMS will . used closer than 15 cm to sources of power frequency magnetic field, the IMMUNITY TEST LEVEL shall be adjusted as appropriate for the minimum expected distance.

Guidance and manufacturer’s declaration – electromagnetic immunity for all EQUIPMENT and SYSTEMS that are not LIFE – SUPPORTING

Guidance and manufacturer’s declaration – electromagnetic immunity

This Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulse Oximeter should assure that it is used in such an environment.
Immunity Test| IEC 60601 Test Level| Compliance Level
Conducted disturbances included by RF fields a, IEC 61000-4-6 Radiated RF EM fields.’ IEC 61000-4-3| 3 V b, 0.15 MHz – 80 MHz
6 V b) in ISM and amateur radio bands between 0.15 MHz and 80 MHz
80°.6 AM at 1 kHz 10 V/m,
80 MHz — 2.7 GHz di 80°.6 AM at 1 kHz e’| 3 V , 6 V 6, 10 v/m.b`
a, The following apply.
– All PATIENT-COUPLED cables shall be tested, either individually or bundled
– PATIENT-COUPLED cables shall be test., using a current clamp unless a current clamp is not suitable. In cases where a current clamp is not suitable, an EM clamp shall be used.
– No intentional decdupling device shall be used between the injection point and the PATIENT COUPLING POINT in any case.
– Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS. – Tubes that are intentionally filled with conductive liquids and intended to be connected to a PATIENT shall be considered to be PATIENT-COUPLED cables.
– If the frequency stepping skips over an ISM or amateur radio band, as applicable, an additional test frequency shat’ be used in the ISM or amateur radio band This applies to each ISM and amateur radio band within the specified frequency range.
– The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
C Before modulation is applied
., The interface between the PATIENT physiological simulation, if used, and the ME EQUIPMENT or ME EQUIPMENT shall be located within 0; 1 m of the vertical plane of the uniform field area in one orientation of the ME EQUIPMENT of ME SYSTEM.
. ME EQUIPMENT and ME SYSTEM that intentionally receive RF electromagnetic energy for the purpose of their operation shall be tested at the frequency of reception Testing may be perfoed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS. This test assesses the BASIC SAFETY and ESSENTIAL PERFORMANCE of an intentional receiver when an ambient signal is in the passband. It is understood that the receiver might not achieve normal reception during the test.
e, Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS.

Test specifications for ENCLOSURE PORT IMM UNITY to RF wireless communications equipment

Test frequency (MI-lz)| Band. (MHz)| Service al| Modulation°,| Maximum power (W)| Distance (m)| IMMUNITY TEST LEVEL (Vim)
---|---|---|---|---|---|---
385| 380-390| TETRA 400| Pulse modulation °)| 2.| 3| 27
| | | 18 Hz| | |
450| 430-470| GMRS 460. FRS 460| FM. ± 5 kHz deviation| 2| 0,3| 28
| | | 1 kHz sine| | |
710| 704-787| LTE Band 13, 17| Pulse modulation °)| 0.2| 3| 9
745| | | 217 Hz| | |
780| | | | | |
810| 800-960| GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5| Pulse modulation °)
18 Hz| 2| D 3| 28
870
930
1720| 1700-1990| GSM 1800;| Pulse modulation pl| 2| 0.3| 28
1845| | CDMA 1900;| 217 Hz| | |
1970| | GSM 1900;| | | |
| | DECT;| | | |
| | LTE Band 1, 3, 4, 25, UMTS| | | |
2450| 2400-2570| Bluetooth, WLAN, 802.11 h/g/n, RFID  2450, LTE Band 7| Pulse modulation ‘l 217 Hz| 2| 3| 28
5240| 5100-5800| N.J. 802.11 a/n| Pulse modulation °.| 0.2| 3| 9
5500| | | 217 .| | |
5785| | | | | |
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna
and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC
61000-4-3.
, For some services, only the uplink frequencies are included.
°, The carrier shall be modulated using a 50 % duty cycle square wave signal.
., As an alternative to FM modulation, . % pulse modulation at 18 . may be used because while it does not
represent actual modulation, it would be worst case.

References

• electric.al
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