GGM ™
HUMIDOFLO HFT SYSTEM HF-2900D Operation Manual
Rev. J
2020/07/16
Great Group Medical Co., Ltd. No.168, Xingong 2nd Rd., Tianzhong T Township, ownship, Changhua County 520, Taiwan Tel:+886-4-875-8181 Fax:+886-4-875-6161 E-mail:
[email protected] Website:www.greatgroup.com.tw ISO 13485 / CE 2460 / GMP
Contents Notes .......................... ....................................... .......................... ........................... ........................... ........................... ........................... .......................... ........................... ........................... ................ ... 2 Caution Cauti on ......................... ...................................... ........................... ........................... ........................... ........................... .......................... .......................... ........................... ........................... ............... 2 Warning Warni ng ........................... ........................................ .......................... ........................... ........................... .......................... .......................... ........................... ........................... ......................... ............ 2 1. Introduction of HF-2900D .................................................................................................................... 5 1.1 Application & Description .......................................................................................................... 5 1.2 Intended Use ............................................................................................................................. 5 1.3 Contraindications ...................................................................................................................... 5 2. Product Specification .......................................................................................................................... 6 2.1 Operating on environment ............................................................................................................. 7 2.2 Statement Environmental Issue ............................................................................................. 7 3. Appearance Description ...................................................................................................................... 8 4. Humidifier Installation Instructions ..................................................................................................... 9 4.1 Power Installation before use .................................................................................................... 9 4.2 Chamber and tubing Installation ................................................................................................ 9 4.3 Nasal Cannula Installation ....................................................................................................... 12 4.4 Oxygen inlet tube Installation (Optional device) ....................................................................... 13 4.5 Physiological signals Sensor Probe Installation ......................................................................... 15 5. Operating Instruction ........................................................................................................................ 16 5.1 Control panel ........................................................................................................................... 16 5.2 Function Button Description .................................................................................................... 17 5.3 Patient Mode Selection ........................................................................................................... 18 5.4 Operating Flow Chart ............................................................................................................... 19 5.5 Power on Display Description .................................................................................................. 21 5.6 Operate/Monitor Screen Description ....................................................................................... 22 5.7 Operating/Monitor Display Set up Flow Chart .......................................................................... 23 5.8 Function Set Up Description ..................................................................................................... 24 5.9 Function Set up Flow Chart ...................................................................................................... 28 5.10 Alarm System Description ...................................................................................................... 34 6. Cleaning and Maintenance ................................................................................................................ 36 6.1 Shell Shell .......................... ........................................ ........................... .......................... .......................... ........................... ........................... .......................... ........................... ................. ... 36 6.2 Cleaning .................................................................................................................................. 36 6.3 Maintenance ........................................................................................................................... 36 6.4 Monthly Checks ....................................................................................................................... 36 6.5 Accessories Replacing Schedule ............................................................................................... 37 7. Necessary Accessory and Recommend Recommend Accessary to use with the Device ...................... ........... ..................... ................ ...... 38 7.1 Necessary Accessory ................................................................................................................ 38 7.2 Recommend Accessary ............................................................................................................ 38 7.3 Optional Table ......................................................................................................................... 39 7.4 USB storage disc instruction for use ......................................................................................... 40 8. Revision History ................................................................................................................................ 41 Annex A EMC Table ............................................................................................................................... 42 Annex B. Troubleshooting ..................................................................................................................... 44
1 Ref. HF-PS-2900213 Rev. J
Note and Caution and Warnings: Note: Possible be misunderstood or ignored the steps, to provide additional information. Warning: indicates that a situation may occur which is potentially harmful to the patient or user. Caution: indicates a condition that may lead to equipment damage, malfunction, or inaccurate operation.
Notes Please read the instruction manual, the notes and the warnings carefully before operating. This User Manual applies to the unit with Firmware version V3.00 and above. N1. The unit can only be used by trained operator. N2. Do not use the unit near any flammable anesthetics. anesthetics. N3. Do not repair or relocate the unit when the patient is using. N4. Users will need to check for its safety performance to ensure the function works completely. N5. Do not open the housing, internal issues should be handled by GGM authorized personnel. N6. Avoid collision and intense shaking. N7. The unit should be set at the place lower than the patient head level to prevent water from entering the breathing tube. N8. Humidity output will be influenced below 18°C (64°F) and above 28°C (82°F). N9. Please read the operating manual include the warnings carefully, otherwise may lead to injury. N10. Please make sure that all accessories (connecting line USB storage disc and Physiological signals Sensor) and tube(breath tube and pressure tube) are connected before turn on the power. Select the appropriate nasal tube interface. N11. The unit has several timer functions. New patients should notice the status of the timer. Set the N11. timer to zero if necessary. More details please refer to §5.8.C.
Caution C1. The unit is not intended for life support. C2. The unit is not intended for patient monitoring system. system. C3. Delivery of respiratory gas through nasal will generate flow-dependent positive airway pressure (PAP). Please consider the possible adverse reaction of patient to PAP. C4. Using the breathing tube or interface over two weeks may result in serious injury, such as infection. Please read the relevant accessories instructions carefully. carefully.
Warning Breathing tube and interface: W1.Do not use any accessories that are not listed in the instruction manual of the humidifier or the accessories, because unlisted accessories may cause the humidifier not operate normally, and affecting the treatment or harming the patient. patient. W2. The unit should only be used with interface, chamber and breathing tube specified in the user manual. W3. Never block the air openings of the unit or place it on a soft surface such as a bed or couch/sofa, where the filter area may be blocked. Keep the air openings free of lint, hair etc. W4. Do not make any change to the breathing tube or interface. Humidity output will be influenced when tubes are covered with a blanket, or heated it in an incubator or overhead heater for a neonate. W5. Before supplying oxygen, read all warnings in the “Oxygen” section of this manual. W6. Never operate the unit if: 1. The heated breathing tube has been damaged. 2. Malfunction. 3. The case screws have ever been loosened.
Electrical safety: 2 Ref. HF-PS-2900213 Rev. J
W7. The unit’s power cord only can be connected to medical grade power socket. W8. When the voltage fluctuation exceeds the rated voltage ±10%, suggest to use of an AC voltage regulator. W9. To avoid the risk of electric shock, the unit must be connected to a power socket with grounding wire. W10. Ensure that the unit is dry before plugging into the power socket. W11. Disconnecting the power cord from the AC mains is the only recognized disconnect method. W12. Use a power cord that matches the voltage of the power outlet, which has been approved and complies with the safety standard of your particular country. W13. When handling the heaters with the water chamber in place, avoid tilting the machine to prevent any chance of water entering the unit enclosure. W14. Never operate the unit if: 1. It has been dropped or damaged. 2. It has a damaged power cord or plug. 3. It has been dropped into water. W15. Avoid unnecessary removal of the power cord from the rear of the device. If removal is necessary, hold the connector during removal. Avoid pulling on the power cord. W16. Return the unit to an authorized service center for examination and repair, except as outlined in this manual. W17. Do not store or use the unit where it may fall or be dragged into water. If water has entered the unit enclosure, disconnect the power cord and discontinue use. Consult medical staff advice. W18. When the equipment is connected to correspond socket has “Hospital Only” or “Hospital Grade” refersto toanalog the grounding can meet the requirement. requirement W19. Mark, Connected and digital interface’s equipment. must through all relevant IEC standard certification (Suitable for medical equipment IEC 60601-1).In addition, furthermore all configurations shall comply with the system standard IEC 60601-1-1.Anyone who connects additional equipment to the signal input part or signal output part configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 60601-1-1. W20. There will be adverse effects on the performance when the unit is exposed to, for example, electrocautery, electrosurgery, defibrillation, X-ray (gamma radiation), infrared radiation, conducted transient magnetic fields including magnetic resonance imaging (MRI), and radiofrequency interference. W21. Portable and mobile RF communications equipment can affect medical equipment and should not be used near the unit.
To avoid choking or inhalation of other objects: W22. Ensure an air filter is fitted when operating your unit. W23. Never drop or insert any object into any opening or tube.
When operating the unit, it should be avoided: W24. Do not change different size of nasal tube or connect /remove the Physiological signals signals Sensor while the unit is under using. W25. Do not apply infant nasal cannula under adult mode. W26. Do not apply adult nasal cannula under infant mode. W27. Do authorization of the manufacturer. W27. Do not modify this equipment without authorization
3 Ref. HF-PS-2900213 Rev. J
Disposal instructions Unit Disposal Instructions: Instructions: According to the EU-wide legislation, waste electrical and electronic products carrying the mark(left) must be disposed of separately from normal household waste. This includes monitors and electrical accessories, such as signal cables or power cords. When you need to dispose of your display products, please follow the guidance of your local authority, or return the product to GGM Co., Ltd. Consumables Disposal Instructions: Instructions: Place the interface, breathing tube and chamber in a waste bag at the end of use. Hospitals should discard according to their standard method for disposing of contaminated product.
HUMIDIFIER HF-2900D Symbol definition:
Drip Proof
Alternating Current
Warn Electrical Shook Hazard
Warn Surface Temperature
Off (Power)
Do Not Throw Away
Power (Stand By)
Do Not Reuse
Function Locked
Alarm Paused
Sound Off
Sound Pause
Low Priority Alarm
Medium Priority Alarm
High Priority Alarm
Chamber Outlet Temperature
Airway Outlet Temperature
Patients With
Fraction Of
Proximal Pressure
Inspired Oxygen
Saturation Pulse Oximeter
Pulse Rate
Type BF
Consult Instruction For Use
Caution Consult Accompanying
Ground Protection
On (Power)
Alarm Off
Flow
Notified Body
Thank you for using Great Group Medical Co., Ltd.’s production. p roduction. In order to operation this equipment, please read the operating manual carefully and strictly comply with the standard operation. Complete technical description contains circuit diagram, BOM, service information, it can get from the product seller. The product uses to operate by qualified medical staff. Before using the unit, please confirm the operator can use Heaters and Humidifier familiarly.
4 Ref. HF-PS-2900213 Rev. J
1. Introduction of HF-2900D 1.1 Application & Description Description Respiratory gas humidifier humidifier is use to deliver high flow warmed and humidified respiratory gases to patients. Such equipment is generally included in tandem, gas, heating, and pre-filled humidifier. The unit is a respiratory therapy device that contains a built-in servo-controlled high-flow generator. The gas will be delivered to the patient and provide humidity and temperature. Also, quantitative oxygen can be added to make it uniformly mixed in advance. The unit will need to operate with the breathing circuit which contains the heater wire. The temperature and the humidity are generated by the gas through the heated water. And the heater wire maintains temperature and humidity from the breathing circuit between the chamber and the patient. patient. The temperature sensor probe at the patient side can accurately control the temperature and measure it. The using of the two heating system can also control the humidity input at the patient side. side.
1.2 Intended Use The unit is intended for treating spontaneously breathing patients (include intubated patients) who require warmed and humidified high-flow respiratory gases within the long-term care and hospital settings.
1.3 Contraindications The unit is not suitable for use in the presence of flammable anesthetics, but that does not contain pure oxygen or first check with the manufacturer of gas and anesthetic degradation does not occur before usage. usage. Contraindications Maxillofacial trauma Nasal obstruction, e.g. choanal atresia, nasal polyps, adenoids Nasal passage abnormalities or recent nasal surgery Presence of suspected base of skull fracture Reduced level of consciousness Life threatening hypoxia Foreign body aspiration Open Chest wound / Chest trauma Respiratory arrest or peri-arrest / apnea Patients at risk of acute hypercapnic / Type 2 respiratory failure secondary to oxygen delivery CPAP/ NIV Contraindication Contraindication Complication Local trauma, discomfort and pressure areas
Epistaxis Excessive PEEP in neonates leading to pneumothorax Gastric Distension Blocked cannula due to secretions Failure of HFNC might cause delayed intubation and worse clinical outcomes in patients with respiratory failure (Kang et al, 2015)
5 Ref. HF-PS-2900213 Rev. J
2. Product Specification Table1.Specification REF
Mechanical
Dimensions
HF-2900D-115 / HF-2900D-230 W350 *D 180* H170 (mm)
Weight
2.54Kg (w/o chamber fitted)
Supply voltage Supply frequency frequency
Electrical Rating Rating
Heater capacity Heater capacity
Performance Performance
HF-2900D-230: 200-240 V~ 2A 50 / 60 Hz
wire 60W Max. plate
Safety protection
Flow Setting Range Air supply temperature control control Maximum Oxygen Input Input
HF-2900D-115: 100-120 V~ 3A
Adult Mode Infant Mode Chamber end Airway end Flow/Pressure Flow/Pressure
Humidity output (Match VH-3141) VH-3141)
150W@ 110°C Max. 115±3°C Cutoff （manual reset type） Over heat Over current 2A(fast blow type) 10-60L/min (step= 5L/min) 2-25L/min (step= 1L/min) Chamber temp. range 31-37°C (preset 34°C) Airway temp. range 32-41°C ( preset 37°C), Airway temp. is always higher at least 1°C than Chamber temp. Max. 60L/min, 10kPa Chamber Set Temp. 31°C 34°C
outlet
37°C
Warm-up time Time Managing
40°C
Output of airway outlet Absolute humidity ≧22mg ≧26mg ≧33mg
10 minutes to 31°C Chamber outlet temp. 30 minutes to 37°C Chamber outlet temp. (@35L/min, Room temperature 23±2°C) 3 Timer Safety
Standard Compliant
Airway outlet Set Temp. 34°C 37°C
Particular Applied Type Electric Shock Protection Water proof and Drip proof
Air Filter Timer Patient Treating Timer Total Operating Timer IEC/EN60601-1、IEC/EN60601-1-2 EN ISO8185 BF Type Class 1 IPX1
6 Ref. HF-PS-2900213 Rev. J
Table 2. Alarm Limit Technical Alarm
Temperature Alarm
Time Management
FIO2 SPO2 Pulse Rate Pprox
Electrical Malfunction Ventilation Abnormal
Internal unit malfunction alarm External accessories malfunction alarm Nasal cannula off Nasal cannula block Airway Temp High Alarm(42°C)./Chamber Temp High High Temperature Alarm(60°C) Alarm Heater plate/Blower High Temperature Alarm Low Temperature Airway Temp Low Alarm(29°C continue 10 Min.) Alarm Chamber Temp Low Alarm(26°C continue 10 Min.) Air Filter Using time exceeds 500 hours will show the prompt screen. Using time exceeds 10000 hours will show the prompt O2 Cell screen. 30- 100%( preset 75%)。 High alarm 21- 29%( preset 25%)。 Low alarm 96- 100%( preset 100%)。 High alarm 85- 95%( preset 85%)。 Low alarm 90- 180BPM(preset 120BPM)。 High alarm 35- 50BPM(preset 40BPM) 。 Low alarm 11- 40cmH2O(preset off)。 High alarm 0.1-10cmH2O(preset off) 。 Low alarm
Table 3. Display range Gas Temperature Measure
Oxygen Concentration Measure Patients with proximal pressure Measure Physiological signal Measure
Range:10 - 80°C Accuracy:±1°C (@25- 45°C) Range:21 - 100% Accuracy: ±(2.5% +2.5% gas level)% Sensor Use Time:Under normal medical environmental conditions can use one year/10000 hours hou rs Range:0-100cmH2O Accuracy:±2cmH2O SPO2 Measure:35- 100%(70- 100%:±2%) Pulse Rate Measure: 35- 250 BPM (±2BPM)
2.1 Operating environment 2.1.1 Operating Condition Room Temperature: 18 to 28°C 28°C (64 (64 to82°F) Relative Humidity: 30 to 75 % The Altitude: 2000 meter Operating Mode: Continuous Operating Maximum Operating pressure: 10 kPa, The gas leakage volume ≦150ml/min 2.1.2 Transport and Storage Transport and storage environment: Temperature (-10°C to 50°C) Relative Humidity (30% to 95 %) Environmental Environment al pressure (50 kPa to 106 kPa)
2.2 Statement on Environmental Issue GGM is an expert of designing, manufacturing and marketing medical equipment. These activities do not create a great risk to the environment, and therefore it is not viewed as an issue requiring specific management, GGM is certified to ISO13485 and GMP. GGM does recognize the importance of addressing environmental issues, and these are addressed in procedures or by Management Practice as appropriate. Routine audits are carried out as part of the QMS as required by ISO13485 these also include examination 7 Ref. HF-PS-2900213 Rev. J
of Environmental issues, health and Safety as well as the Quality Management aspects. The Company Secretary has been appointed to monitor environmental developments and to take action to ensure that GGM’s activities impact on the environment is minimized. Actions taken include: All clean cardboard and paper waste is collected for recycling at GGM Program in place to improve energy efficiency through premises management Use of near home worker where suitable to minimize unnecessary travel Use of electronic data transmission and storage to minimize the use of paper, where this is cost effective and available.
3. Appearance Description Table 4. Appearance Description Appearance Description Description of the HF-2900D 1 Control panel 6 Overheat protection switch reset hole 2 Air outlet 7 Carts with fixed screw holes (M5) 3 Pressure detection hole 8 Signal input hole(3.5mm/4Poles) 4 Heater wire breathing tube 9 Data storage storage hole (USB) socket 5 Heated aluminum plate 10 Cable tie
11 Power button 12 Power socket 13 Oxygen input hole 14 Air input hole
8 Ref. HF-PS-2900213 Rev. J
4. Humidifier Installation Instructions Before starting the system, make sure the safety of patients, operators and equipment.
N12. The unit working environment should accord the following requirements requirements:: Temperature 18-28°C W28. The unit’s power cable can only be connected to medical grade power socket.
4.1 Power Installation before use The device body needs to be fixed and placed on the flat desktop before using.
N13. Ensure that the unit is always positioned lower than the patient. N14. The unit must be connected to the power socket (protective earth type), grounding must comply with national regulations. N15. The unit do not use in flammable or explosive environments. environments. N16. The unit must be used by trained personnel. N17. If the equipment fails, do not disassemble or assemble the system, and contact authorized service personnel. a. Plug the power cord into the power socket tightly, see Fig. A1.
Fig.A1.
b. Strongly recommended that the cord be secured to the socket with a cable tie, see Fig. A2.
Fig.A2
Chamber and tubing Installatio Installation n with the aluminum disc outer groove, Push the chamber on 4.2 a. Press the aluminum pan guard, aligning firmly until the finger guard clicks into place, as Fig. B1
Fig.B1
N18. Select a suitable GGM humidification chamber. Refer to the chamber instruction sheet for chamber details. Ensure that the chamber base and heater plate are undamaged, clean and dry. dry. N19. If using any other GGM chamber, fill with sterile, s terile, deionized water to the maximum water level line. line. N20. To remove the chamber, push down on the finger guard. Pull the chamber forward until the rim is 9 Ref. HF-PS-2900213 Rev. J
just touching the finger guard. Remove fingers from the guard and pull the chamber the rest of the way off the heater plate. Use this technique to avoid touching the hot heater plate or chamber base. C5. Don’t touch the heated aluminum surface, its temperature may exceed 85°C. The rest can touch the metal surface temperature may exceed 55 °C. °C. C6. The breathing circuits and the chamber need to be replaced frequently to comply with the hospital infection control process. b. Connect the blue connector to chamber and connect the white one to the machine, as Fig. B2. c. Connected the heater wire circuit from the chamber outlet port, as Fig. B3. B3.
Fig.B3 Fig.B2.
breathing reathing tube and the device, as Fig.B4. d. Connect the pressure detection tube to the ports on the b
Fig.B4
10 Ref. HF-PS-2900213 Rev. J
e. Connect the heater wire adaptor cable to the heater wire circuit, as Fig B5, and fix it with hose clip, as B6. N21. The adapter plug is directional. Please connect it according to the marked direction. Improper connection will cause damage to the device. N22.The sensor to display the gas temperature of the device is placed inside the device connector and the patient end of the breathing tube. If there is any damage, please replace the new tube.
Fig. B5 Fig. B5
Fig. B6 Fig. B6
f. Connect the chamber and the water bag, as Fig.B7. If used auto feed chamber, please let sterile water bag dangly on heated humidifier and sterile water will automatically recharge to the auto feed chamber.
Fig Fig.. B7
N23. If it is used a non-auto feed chamber, the water supplement should be checked regularly. regularly. N24. Using Using the unit in unit in the hospital, please use distilled water bag. N25. Using the unit unit in home care, it is recommended to use distilled water bag, if you do not have distilled water, use “clean” drinking water to fill the chamber. C7. DO NOT fill the chamber above the maximum level line. Water will enter the breathing circuit if the chamber is overfilled. C8. DO NOT fill the chamber with water in excess of 37°C. Table. 5 Water bag usage time L/min hrs.
Flow Setting vs. usage time (1 liter sterile water bag, chamber temp. 37°C, ambient 23±2°C) 2 5 10 15 20 25 30 35 40 45 50 55 >120 101 50 33 25 20 16 14 12 11 10 9
60 8.4
11 Ref. HF-PS-2900213 Rev. J
g. Connect the Nasal-cannula and breathing tube, as Fig.B8. If it is not connected well with the breathing ca nnula. tube and causes the tube off, the patient expired gases will contaminate the nasal cannula. N26. When the device is connect the infant nasal cannula under the infant mode, the Pprox value displays on the screen means the pressure inside the breathing tube, not the proximal pressure of patient end.
Fig. B8
4.3 Nasal Cannula Installation Please use the appropriate size of nasal cannula for patient. When body weight is less than 10 kg, fflow low rate setting is body weight multiplied by 2L/kg/min. Other case body weight is more than 10 kg, flow rate setting is the remaining weight of body weight multiplied by 0.5 L/kg/min.( Reference: High Flow Nasal Prong HFNP oxygen guideline) e.g. body weight 6 kg, Flow rate = 6 kg * 2 L/kg/min = 12 L/min e.g. body weight 16 kg (10 kg + 6 kg), Flow rate = (10 kg * 2 L/kg/min) L/ kg/min) + (6 kg * 0.5 L/kg/min) = 23 L/min e.g. body weight 40 kg (10 kg + 30 kg), Flow rate = (10 kg * 2 L/kg/min) L/ kg/min) + (30 kg * 0.5 L/kg/min) = 35 L/min It should be noted when using the maximum flow limit, the recommendations are as follows: follows:
Table 6. Nasal Cannula and Flow Comparison Chart L/min 5 HFN-1002
5
HFN-1003
5
Applicable weight 10
15
20
25
30
45
50
60
70
12 10
HFN-0001
10
HFN-0002
10
20 30 20
40
HFN-0003
15
30
HFN-0004
15
30
HFN-0011
10
HFN-0012
10
40 30
HFN-0014
15
30
10
HFN-0022
10
HFN-0023 1
HFN-0024*
60
20 15
HFN-0021
55
30
HFN-0013
HFN-0007
40
18
HFN-1004
HFN-0006
35
55 60
30 20
45
15
30
15
30
10
60 70
20 15
40
Recommended flow range according to patient’s body weight and nostril size. Minimum flow rate that the device could support. *1: HFN-0024 is suitable for HF-2970D model (max flow 70LPM) *2: When the flow rate is set below the recommended value (in the light grey range) “Tube off ” alarm may occur when the cannula is not connected to patient. p atient. 12
Kg 3
~
9
3
~
6
5
~
10
<
30
<
50
<
80
<
90
<
30
<
50
<
80
<
90
<
30
<
50
<
90
<
110
<
10
<
50
Ref. HF PS 2900213 Rev. J
N27. If the using flow rate exceeds the maximum flow limit rate of the nasal cannula, the machine may show a “Tube Block Or Wrong Size” warning. Prolonged use of excessive flow will result in high temperature alarm of the motor. The warning “Motor Temp. Too High” appears. Please use it according to the scope of the comparison table. If the operator does not perform proper processing, processing, after the alarm occurs, the device will automatically reduce the target flow by a corresponding unit every 10 minutes. N28. When the flow rate is set below 5L/min, the detection sensitivity of the tube off and block alarm will be reduced, so it must to use the additional physiologic monitor to observe the status of patients. patients. a. Wear a neck lanyard and Nasal-cannula, as the Fig. C1. C1. b. Adjust the tightness of the Nasal-cannula, as the Fig. C2. C2. c. Adjust the tightness of the shoulder strap, as the Fig. C3 C3
Fig. C1
Fig.C3
Fig. C2
C9. Before using nasal-cannula to patients, the gas heated of the temperature should notice be warm and comfort C10. Unless the cause and effects of any alarm are understood and assessed to be of no hazard to the patient, the humidifier should be immediately switched switched off and disconnected from the patient.
4.4 Oxygen inlet tube Installation Installation (Optional device) a. Unplug Oxygen Inlet cover, and connect oxygen inlet adapter the inlet port, see Fig.D1. b. Adjustment the oxygen flow from flow meter or Oxygen concentrator to offer suitable concentration of oxygen, see Fig. D2.
Fig. D2
Fig. D1
Oxygen concentration measured point
13
Ref. HF PS 2900213 Rev. J
Fig. D3 c. In the process of supplying oxygen, the mixed gas flow to patients from the unit is a fixed value, and not changed by the adjustment of the oxygen flow rate. rate. mixing ratio of oxygen and air in the d. Oxygen concentration, please refer to 「FIO2 Table」 to know the mixing different flow of the device.
C11. If oxygen is not used, please cover the dust cover back to the air inlet port to avoid the patient injury caused by inhalation of dust and other harmful substances. N29. The oxygen detection alarm function is preset to be turned off when the device is turned on. Only when the oxygen supply concentration reaches (Table 11. The oxygen concentration is too low), the function of oxygen detection alarm will start. N30. When breathing tube or patient interface is blocked, oxygen output will be influenced. Table 7. FiO2 Table FiO2 Table
Unit:%
Flow Setting of the Machine
lo
2
O w
F
2L
3L
4L
5L
6L
7L
8L
9L
10L 10L
15L
20L
25L
30L
35L
40L
45L 45L
50L
55L
60L
0L
21
21
21
21
21
21
21
21
21
21
21
21
21
21
21
21
21
21
21
1L
52
41
36
34
33
31
29
28
27
25
24
24
23
23
23
23
22
22
22
2L
90
70
56
48
44
41
38
36
35
30
27
27
26
25
25
24
24
23
23
3L
95
90
73
63
57
53
49
46
42
34
31
29
28
27
26
26
25
25
25
4L 5L
99
99
91 99
79 91
70 81
64 73
58 67
54 61
49 55
39 44
34 38
32 35
30 33
29 31
28 30
27 29
27 28
26 27
26 27
99
91
83
76
69
62
49
41
38
35
33
32
30
29
29
28
98
91
85
77
70
54
44
41
37
35
33
32
31
30
29
98
91
85
78
58
48
43
40
37
35
34
32
31
31
97
91
85
63
51
46
42
39
37
35
34
32
32
10L
96
91
68
55 55
49
45
41
39
37
35
34
33
11L
99
96
72
59 59
52
47
43
40
38
36
35
34
99
78
62
55
49
45
42
40
38
36
35
13L
83
65
57
52
47
44
41
39
38
37
14L
85
69
60
54
49
46
43
41
39
38
15L
90
73
63
56
51
47
44
42
40
39
6L 7L 8L 9L
12L
14
Ref. HF PS 2900213 Rev. J
FiO2 Table
Unit:%
Flow Setting of the Machine 2L
3L
4L
5L
6L
7L
8L
9L
10L 10L
15L
20L
25L
30L
35L
40L
45L 45L
50L
55L
60L
91
77
68
62
57
53
49
47
45
91
80
72
65
60
57
53
51
92
83
75
69
64
60
57
92
84
76
71
66
63
92
84
78
73
69
91
84
79
74
50L
93
86
81
55L
99
92
87
99
93
20L 25L 30L 35L 40L 45L
60L 65L
99
The internal FiO2 Table of the machine is the result calculated by the ideal formula. The value is for reference only. Please take the actual value measured by Oxygen Cell as principal. principal. Table 8. FiO2 Measurement Error FiO2 Measurement error table Standard value 21% Error value ±3%
40% ±3.5%
60% ±4%
80% ±4.5%
100% ±5%
Error formula: = ±(. % + . . % % )% )%
4.5 4.5 Physiological Physiological signals Sensor signals Sensor Probe Installation a. To open the right side of the device signal input hole. hole. b. The Physiologic Physiological al signals signals Sensor Sensor probe connected to the right side of the device signal input hole, such as the Fig.E1 (Physiologic Physiological al signals signals Sensor Sensor probe is optional, please refer to section 5.5) 5.5)
Fig. E1
W29. If the device is power on, do not remove or plug in the Physiological signals Sensor probe. W29. If W30. Improperly use could result in inaccurate measurement. W31. When the light is too strong lead to inaccurate measurement, please putting to opaque fabric around the sensor. W32. At least every four hours get reusable sensor move to a new part. Due to local skin condition will affect the ability of the skin sensor positioned ability. 15
Ref. HF PS 2900213 Rev. J
W33. The intravascular dye will result in poor measurement effect. W34. Performance susceptible to activities effect, therefore measurement remains static posture. W35. Do not use the strap to bind sensors, because venous pulsation can cause measurement inaccurate. W36. As with other medical devices, cables should be placed well in order to avoid twining or suffocation patient. signals Sensor Sensor probe when performing performing an MRI scan because the conductor W37. Do not use Physiological Physiological signals current can cause burns and affect the MRI image, and MRI also affect the accuracy of the oximetry. W38. Do not pull on the sensor cable because the cable may loosen from the conductor, causing the device to hit the patient. W39. Do not make any clinical judgments based solely on this unit. The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.
5. Operating Instruction 5.1 Control panel
Fig. 5.1
Table 9. Display Description Description Figure
LED
LED Indicator Description Status
Description
Green
Adult operating mode
Constant light or flicker
Green
Infant operating mode
Constant light or flicker
Green
Data storing Mode
Constant light: USB connecting。 Flicker: Data loading
Yellow
Warning indicator
Flicker When alarm works
16
Ref. HF-PS-2900213 Rev. J
5.2 Function Button Description Table 10. Function button Button Function Description Stand by: Turn on/Turn off 1. After the machine is connected to the power cord and the main power switch ON / OFF behind the machine is turned on, press this button for 2 seconds and it will beep once to boot. 2. In any screen, after pressing this button for 3 seconds, the machine will automatically shut down with two beeps. NEXT/RETURN button: 1. Switch to the next screen. 2. It is used to confirm after the function selected. 3. Press it for 3 seconds to return to the main screen when it is in the function adjustment screen. 4. At start-up screen, press this button for 2 seconds, and then it can enter to select the【Infant/Adult】Patient mode. UP button: 1. To increase the select setting or to change the patient mode. Down button: 1. To decrease the select setting or to change the patient mode.
Press these two buttons at the same time to unlock the function setting lock.
Mute/Alarm Paused: 1. Mute: Press the button after the alarm rang, the unit will mute temporarily and the screen will show a countdown timer. Unless the alarm status was cleared, otherwise the alarm will ring again. 2. Alarm paused: Before executing a state that is known to cause the alarm, press the button can avoid the alarm rang.
17
Ref. HF-PS-2900213 Rev. J
5.3 Patient Mode Selection 1. Press the power button for 2 seconds, the screen will display the device number and version for 5 seconds. During the 5 seconds, press for 2 seconds to enter the patient mode selection (adult/infant mode). 2.Press ▲ to select the adult mode, and press ▼ to select the infant mode.
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Ref. HF-PS-2900213 Rev. J
5.4 Operating Flow Chart
19 Ref. HF-PS-2900213 Rev. J
A
B 4
C
1
2
D
E
1
2
3
4 2
3
20
Ref. HF-PS-2900213 Rev. J
5.5 Power on Display Description Description
Screen
Press the On/Off button to start the unit. Screen will show product number/software revision and then it will switch to next display automatically. automatically.
Display the patient mode and then the screen will switch to next display d isplay automatically. automatically.
Warm up screen: system start to warm up, heater plate/heater wire /blower activate, and display the “FLOW” & “Chamber Temp” & “Airway Temp” Screen will
switch to next display. (Flow and temperature will base on last used set point as the initial power default value, and displayed at the top of each graphic symbols.) Ready screen: The warm-up screen is the preliminary screen, indicating that the machine is ready for use. At this time, you can connect the nasal cannula tube to the patient end, and the screen will automatically switch to the next page.
When the outlet temperature of chamber is 31°C, the word “Ready…” will disappear, which means that the machine has completed all settings. This is the main screen I (the initial preset value displayed above each graphic symbol will automatically disappear).
21 Ref. HF-PS-2900213 Rev. J
5.6 Operate/Monitor Screen Description Description Screen
Description Main screen I: Flow symbol: it shows the gas flow provided to the patient Temperature symbol: it shows the chamber outlet gas temperature. Temperature symbol: it shows breathing tube end gas temperature. Press to switch to the main screen II. Main screen II: FiO2 Symbol: Percentage of oxygen concentration in inhaled gas Proximal airway pressure symbol: it shows the inside gas pressure of the nasal cannula near the patient end. Press to switch to the main screen III. Main screen III (when the physiological sensor is connected to the unit): SPO2 symbol: Display blood oxygen saturation and pulse strength. Heart Rate Symbol: Display number of beats per minute Press to switch to the main screen IV. Main screen IV: Function setting screen, when the machine is turned on after 1 minute, the lower left corner will appears a lock to prevent the important machine parameters change. Press will return to the main screen I. If you want to enter the function set up, press buttons at the same time to unlock the screen to enter the set up mode.
When it is unlock, press
, then the screen will switch to the main screen I.
22 Ref. HF-PS-2900213 Rev. J
5.7 Operating/Monitor Display Set up Flow Chart Turn on the main power. "Beep" "Beep" two sound means the machine is in the standby mode.
Press the
button for 2 seconds.
GGM HF-2900 Ver2.00
When the power is on, the screen will display the manufacturer manufactur er brand, model number and the version, and then it will automatic automatically ally switch to the next screen. ※Press the
button for 2 seconds while the power is on, and the screen will enter the patient mode selecting list (adult mode and infant mode).
Warm-up.
The machine is ready for use.
Main Screen I The preset screen will display the current flow, the C temperature and the A temperature.
Main Screen II Show the FIO2 and the Pprox separately. Main Screen III Show the SPO2 and the heart rate separately.
N31. Only when the physiological sensor is connected, the screen will show this information. Main Screen IV Function set up. (It needs to be unlocked to enter this selecting list.)
23 Ref. HF-PS-2900213 Rev. J
5.8 Function Set Up Description Screen
Description The picture on the left is the unlocked screen. Press at the same time, the lock symbol () will disappear. Then, it can enter to the function set up mode. Press
to enter the main screen of function set up.
Main selection list of the function set up A. Parameter: Parameter: Set up the Flow, Chamber end temperature and Airway temperature. B. FiO2 Table: O2 concentration comparison table. C. Timer: The Timer: The operating time of the filter, the patient and the device. device. D. Alarm Limit: The alarm limit setup. E. Other: Other settings. F. Return: Return to the main screen I. A. Parameter Parameter set up screen A.1 Flow rate setting: Press (increase) or (decrease) to set up the flow. (The picture on the left shows the default of adult mode 15L/min.) 15L/min.) Press
to enter to the screen A.2.
Parameter set up screen A.2 Chamber outlet end temperature setting: Press to set up the temperature. Press
or
to enter the screen A.3.
Parameter set up screen A.3 Airway temperature setting: Press temperature. Press
or
to set up the
to return to the main screen.
B. FiO2 Table Function Setup Display B：O2 concentration table，press / to enter the O2 concentration. The O2 Flow rate will calculate automatically on screen. N32. Users need to adjust the flow meter manually to
change the O2 concentration. Refer to the Table 4.4 FIO2 Table. Pres Presss
and and re retu turn rn to th the e main main func functi tion on setu setup. p. 24
Ref. HF-PS-2900213 Rev. J
C. Timer 1.Filter：Ventilation filter timer will display “Filter Expire” automatically while operating after 500 hours. Please inspect the quality of the filter, if it had any discoloration, dirt or dust, please replace it regularly. 2.Patient：Patient treating timer will accumulate the time continuously. It should be reset to zero in the end of the treatment for the new patient use. 3.Runtime：The total operating time. 4.Return：Return to main function setup. Ventilation
filter
timer
will
display
“Filter
Expire”
automatically while operating after 500 hours. After replacing it, please select the below in the main setup display. Press
Yes to reset to zero.
Press
No to cancel.
The timer should reset to zero before using on the new patient. Press
Yes to reset to zero.
Press
No to cancel.
D. Alarm Limit 1. FiO2: The High and the Low limit；Close the function. 2. SPO2: The High and the Low limit ；Close the function. The High and the Low limit；Close the function. 4. Pprox: The High and the Low limit；Close the function. 5. Default: The high and low limit values of various alarms are restored to factory preset values; refer to Chapter 2 Product Specifications. 6. Return: Return to setup the main screen.
Set up the FIO2 parameter：The High alarm (Default: 75%) “Off” means to disable the alarm and the monitor function.
25
Ref. HF-PS-2900213 Rev. J
Set up the FIO2 parameter：The Low alarm (Default: 25%) “Off” means to disable the alarm and the monitor function.
FIO2 parameters setup completed. Press ess
to return to to Dis Display D.
Set up the SPO2 parameter：The High alarm (Default: 100%) “Off” means to disable the alarm and the monitor function.
Set up the SPO2 parameter：The Low alarm (Default: 85%) “Off” means to disable the alarm and the monitor function.
SPO2 parameter setup completed. Press ess
to return to to Dis Displa play D.
Set up the Pulse Rate parameter ： The High alarm (Default:120BPM) “Off” means to disable the alarm and the monitor function.
Set up the Pulse Rate parameter ： The Low alarm (Default:40BPM) “Off” means to disable the alarm and the monitor function.
Pulse Rate parameter setup completed. Press ess
to return to to Dis Display D.
Set up the Proximal Pressure parameter: The High alarm (Default: off). “Off” means to disable the alarm and the monitor function.
26
Ref. HF-PS-2900213 Rev. J
Set up the Proximal Pressure parameter: The Low alarm (Default: off). “Off” means to disable the alarm and the monitor function.
Proximal Pressure parameter setup completed. Press ess
to return to to Dis Display D.
Default：Preset the parameters；Refer to §2 specification.
Press for 3 seconds can return to the Main Display. Idle for over 5 seconds will also return to the Main Display.
E. Other 1. Language Setting: Display language setting. 2. Back Light: Setting the time to turn on the backlight. 3. Button Lock: Setting the time to lock the button automatically. 4. Return: Return to the main screen.
Select the display language to set up.
Setting the time to turn on the backlight: 1. Select “On” means backlight keep lighting, never off. 2. Select “1-10” means the time that backlight will keep lighting (minutes). (Default: Backlight keep lighting for 1 minute.)
Button lock automatically setting: 1. Select “Off” means button keep unlocking, never lock. 2. Select 1-10 can set the unlock time (minutes). (Default: Temporary unlock is 1 minute.)
27
Ref. HF-PS-2900213 Rev. J
5.9 Function Set up Flow Chart Enter/Leave the Main Function Setup The device is ready for use. Main Screen I: The preset screen will display the current flow, the C temperature and the A temperature. temperature.
Press to enter to the Main Screen IV to show the function set up screen. screen.
Press to unlock and enter to the set up mode. E. Return: Return to the Main Screen I.
Function set up A. Parameter
Function set up selection list A. Parameter: Set up the Flow, the Chamber outlet end temperature and the Airway temperature.
En Ente terr to th the e flow flow set setting ting.. Pres Presss or to se sett up. up. Adult mode: Flow setting range is from 15 to 50L/min. Each time when you press or , th the flo flow wi will iin ncrease or or decrease 5 L/min. L/min. Infant mode: Flow setting range is from 5 to 15L/min. Each time when you press decrease 1 L/min.
or
, th the fl flow wi will iin ncrease or or
Enter to the Chamber outlet end temperature setting. Press or to set up. Default temperature is 34°C. (The temperature range can be set is 31 to 37°C.)
Ente Enterr to the the Ai Airw rway ay temp temper erat atur ure e sett settin ing. g. Pr Pres esss or to set up. Default temperature is 37°C. (The temperature range can be set is 32 to 41°C.) Airway temperature is always higher than chamber temperature at least 1°C. 28
Ref. HF-PS-2900213 Rev. J
Function Set up B. FiO2 Table
B. FiO2 Table：O2 concentration table
Enter the O the O2 concentration table table Press
to adjust.
or
Function Set up C. Timer
C. Timer：The use time of the device, patient, and the filter. filter .
1.Filter：Show the time used and can reset to zero. 2.Patient：Show the time used and can reset to zero. 3.Runtime：Show the total of the runtime. 4.Return：Return to main function setup.
1.Filter：Show the time used and can reset to zero.
Press setup.
to choose “Yes” to reset to zero, and press
to
Press set up.
to choose “No” to cancel to reset. Press
to
2. Patient: It shows the hour of use of the patient, and it can reset to zero.
Press setup.
to choose “Yes” to reset to zero, and press
to
Press set up.
to choose “No” to cancel to reset. Press
to
29
Ref. HF-PS-2900213 Rev. J
Function Set up D. Alarm Limit
D. Alarm Limit: Set up the alarm limits.
1. FiO2: The High alarm and the Low alarm limit; Close the function. 2. SPO2: The High alarm and the Low alarm limit; Close the function. 3. Pulse Rate: The High alarm and the Low alarm limit; Close the function. 4. Pprox: The High alarm and the Low alarm limit; Close the function. 5. Default: Restore the default. Refer to Ch2 The specification. 6. Return: Return to main function setup.
1. FiO2: The High alarm and the Low alarm limit ；Close the function.
Set up the FIO2 parameter：The High alarm (Default: 75%) Choose Off to close the alarm and the monitor function. Press
or
to set up the high alarm parameter.
Set up the FIO2 parameter：The Low alarm (Default: 25%) Choose Off to close the alarm and the monitor function. Press
or
to set up the low alarm parameter. parameter.
FIO2 parameters setup completed. Press
to return to screen D.
30
Ref. HF-PS-2900213 Rev. J
2. SPO2：The High alarm and the Low alarm limit ；Close the function.
Set up the SPO2 parameter：The High alarm (Default: 100%) Choose Off to close the alarm and the monitor function. Press
or
to set up the high alarm parameter.
Set up the SPO2 parameter：The Low alarm (Default: 85%) Choose Off to close the alarm and the monitor function. Press
or
to set up the low alarm parameter. parameter.
SPO2 parameters setup completed. Press
to return to Screen D.
3. Pulse Rate: The High alarm and the Low alarm limit ；Close the function.
Set up the Pulse Rate parameter ： The High alarm (Default:120BPM) Choose Off to close the alarm and the monitor function. Press Set
or up
the
to set up the high alarm parameter. Pulse
Rate
parameter ： The Low alarm
(Default:40BPM) Choose Off to close the alarm and the monitor function. Press
or
to set up the low alarm parameter. parameter.
Pulse Rate parameters setup completed. Press
to return to Screen D.
31
Ref. HF-PS-2900213 Rev. J
4. Pprox: The High alarm and the Low alarm limit ；Close the function.
Set up Pprox parameter: The high alarm (Default: off). Choose Off to close the alarm and the monitor function. Press
or
to set up the high alarm parameter.
Set up Pprox parameter: The low alarm (Default: off).Choose Off to close the alarm and the monitor function. Press
or
to set up the low alarm parameter.
Pprox parameter set up completed. Press
to return to Screen D.
Function Set up E. Other
E. Other: Other setting.
1. Language Setting: Display language setting. 2. Back Light: Setting the time to turn on the backlight. 3. Button Lock: Setting the time to lock the button automatically. 4. Return: Return to the main screen.
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Ref. HF-PS-2900213 Rev. J
1. Language: Set up display language.
Operating interface interface language is English.
2. Back Light: Set up backlight turn on time.
On means keep lighting, 1-10 means the time to keep lighting (minutes).
3. Button Lock: Set up the time to lock the function operating automatically.
Off means keep unlocking, 1-10 means temporary unlocked time (minutes).
33
Ref. HF-PS-2900213 Rev. J
5.10 Alarm System Description This device has a visual and sound alarm function. The alarm system is divided into technical alarms and physiological state of alarm and the alert status is divided into High priority, Medium priority and Low priority. 5.10.1 Alarm Introduction Table 11. Alarm Information Visual Alarm Symbol Description Alarm Off All or the some of the alarm system any alert. Alarm Pause All or the some of the alarm system any alert in the period. Sound Off All or the some of the alarm system any sound alert. Sound Pause All or the some of the alarm system any sound alert in the period. High Priority
Display screen
(Malfunction (Malfunctio n Symbol)
will not generate
will not generate
will not generate
will not generate
May have potentially irreversible damage. Require immediate operator response. Medium Priority May have potentially reversible damage. Require instant operator response. Low Priority May have potentially slight injury or discomfort. Require operator’s attention
Sound Alarm Sound
Sound Pressure
Description
C-C-C-C-C-
≧55dB
High Priority Require immediate operator response. response.
C-C-C-
≧50dB
E-C-
≧45dB
Mute
Medium Priority Require instant operator response. Low Priority。 Require operator’s attention 1. When an alert occurs, press this button can pause 115 seconds (or longer). 2. After pressing the button, the alarm screen will remain and will have a countdown timer. 3. When some of the alert occurs, long press the button can pause and will ask whether wants to close the partial alert detection.
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Ref. HF-PS-2900213 Rev. J
5.10.2 Alarm Status Base on the risk management control, the interior machine have adopt the priority sorting system. These priorities are set according to the position of operator within 1 meter around the machine. If several alarm occurred, the system would display the High priority alert. alert. These alerts are issued by the intelligent alarm system. The system can process the sensor and the information of the target setting, and compare with the pre-programmed limits. Appendix B 'Troubleshooting' that grouping all definitions are listed from highest to lowest priority alarm conditions and includes their causes, and possible solutions. 5.10.3 Alarm Limit Most alarm limit is programmed in advance. The following are exceptions. The alarm limits can be changed to other values authorized personnel. After a power interruption, these changes will be retained. Table 11. Alarm Limit Status
Default
Available preset values
FiO2 too Low
25%
off,21-29%
FiO2 too High
75%
30-100%,off
SPO2 too Low
85%
off,85-95%
SPO2 too High
100%
96-100%,off
Pulse Rate too Low
40BPM
off,35-50BPM
Pulse Rate too High
120BPM
90-180BPM,off
W40. The operator should check the different alarm default settings for each patient before using. using. W41. If you use different alarm default settings on different machines in single area (such as ICU.) may lead to danger W42. Alarm W42. Alarm limits set to the limit value (off) can cause an alarm system invalidated. invalidated. 5.10.4 Alarm Paused Before causing a known alert, press the mute button at any Main Display will appear " alert pause and countdown timer ( 1:55 ) ," No alarm will sound so that it will not disturb patients .This function is used to provide the necessary patient care nurses , after the end of the operation, press the mute button again will return to the main screen.
35
Ref. HF-PS-2900213 Rev. J
5.10.5 Alarm System Function Inspection You can check the system anytime when the machine is power on. Remove the heated breathing tube. The "breathing circuit off" visual alarm signal should appear and listen to the voice alarm signal. If any alarm signal malfunctions, do not use this instrument. Please contact the Great Group Medical representative. 5.10.6 Sound Information Signal In addition to the sound alarm, it will also provide sound information signal. As follows: Table 13. Sound Information Signal Sound Beep- Beep Beep Beep -
Description Power on. Machine on Function Unlocked
6. Cleaning and Maintenance 6.1 Shell N33. The outer case of the unit is made of plastic. DO NOT use antiseptic liquid or sharp stuff to clean it.
6.2 Cleaning a) It should turn off the power before cleaning. b) Clean the humidifier with recommended disinfectants using a damp cloth: must be used 75% Isopropyl Alcohol.
c) Wipe the humidifier clear of any cleaning residues before use.
6.3 Maintenance It is necessary to avoid pollution by checking facilities and parts regularly. It is suggested contact with in local for maintenance every 12 months.
6.4 Monthly Checks N34. The heater base may be cleaned by using a mop cloth. Check the humidifier cables for damage and replace when necessary. N35. Plug a heater wire assembly into the heater base, switch on and observe that the humidifier conducts the self-test. N36. Observe correct operation of self-test. Check for correct display of ambient temperature and that no alarms are immediately activated. N37. Ensure the surface is clean and free from pitting, gouging etc. These can be removed byheater sandingplate lightly. N38. To replace the filter regularly by month or 500hrs. 500hrs. N39. Keep routine maintenance to ensure safety for continuous usage. usage.
36
Ref. HF-PS-2900213 Rev. J
6.5 Accessories Replacing Schedule Table 14. Accessories replacing schedule Maximum Use of Time
REF. & Description HFN-0001 HFN-0001 HFN-0002 HFN-0002 HFN-0003 HFN-0003 HFN-0004
1 week (Single patient use only)
HFN-0011 HFN-0011 HFN-0012 HFN-0012 HFN-0013 HFN-0013 HFN-0014
2 week (Single patient use only) 1 month or 500 hours 1 year or 10000 hours
Adult nasal 4.0mm 4.0mm Adult nasal 5.0mm 5.0mm
cannula cannula
Adult nasal cannula 6.0mm 6.0mm Adult nasal cannula 7.0mm Inlet Exchangeable Nasal Prong 4.0mm 4.0mm Inlet Exchangeable Nasal Prong 5.0mm 5.0mm Inlet Exchangeable Nasal Prong 6.0mm 6.0mm Inlet Exchangeable Nasal Prong 7.0mm
HFN-1002 HFN-1002 HFN-1003 HFN-1004 HFN-1004
HFN-0021 HFN-0021 HFN-0022 HFN-0022 HFN-0023 HFN-0023 HFN-0024 HFN-0024
Infant nasal cannula 3.5mm 3.5mm Infant nasal cannula 3.0mm Infant nasal cannula 4.0mm
Dual Limb High Cannula 4.0mm 4.0mm Dual Limb High Cannula 5.0mm 5.0mm Dual Limb High Cannula 6.0mm 6.0mm Dual Limb High Cannula 7.0mm 7.0mm
HFN-0006
Tracheostomy cannula 3.5mm
VA-4213-31
Disp. Heater wire breathing circuit (HF type)(w/Pprox tube)
VA-4215-42
Disp. Heater wire breathing circuit (HF type)(w/Pprox tube)
VF-2206
Filter 36*30 36*30
HF-PS-29000 08
Air filter
GTS-OOM102
(Molex 3P) Oxygen Sensor
HFN-0007 HFN-0007
Tracheostomy 5.0mm 5.0mm
Flow Nasal Flow Nasal Flow Nasal Flow Nasal cannula
37 Ref. HF-PS-2900213 Rev. J
7. Necessary Accessory and Recommend Accessary to use with the t he Device N40. This device is suggested to be used with the following accessories. If using any other company’s accessories, it may cause incompatibility. N41. If you do not use the following accessories, the incompatibility problem can result in degraded performance and affect safety.
7.1 Necessary Accessory
Table 15. Box Content Items Part No. 1 HF-2900D-115 2 HF-PS-2900010 HWA-2900G01 HW A-2900G01 3 4
HF-PS-2900211
Contents HUMIDOFLO® HFT system system diagnosis version 115V 115V power cord Heater Wire Single Adaptor English User Manual
7.2 Recommend Accessary Accessary N42. The following accessories comply with ISO 5356-1:2015, and compatible with the device.
38 Ref. HF-PS-2900213 Rev. J
Table 16. 16. Recommend Recommend Accessories to use with the device Items Part No. Contents VA-4213-31 Disp. Heater wire breathing circuit (HF type)(w/Pprox tube) 1 VA-4215-42 Disp. Heater wire breathing circuit (HF type)(w/Pprox tube) HFN-0001 Adult nasal cannula 4.0mm HFN-0002 Adult nasal cannula 5.0mm HFN-0003 Adult nasal cannula 6.0mm HFN-0004 Adult nasal cannula 7.0mm 2 HFN-0011 Inlet Exchangeable Exchangeable Nasal Prong 4.0mm HFN-0012 Inlet Exchangeable Exchangeable Nasal Prong 5.0mm HFN-0013 Inlet Exchangeable Exchangeable Nasal Prong 6.0mm HFN-0014 Inlet Exchangeable Exchangeable Nasal Prong 7.0mm HFN-1002 Infant nasal cannula OD 2.5mm, SD 5.0mm HFN-1003 Infant nasal cannula OD 2.5mm, SD 5.0mm 3 HFN-1004 Infant nasal cannula OD 3.5mm, SD 7.0mm HFN-0021 Dual Limb High Flow Nasal Cannula 4.0mm HFN-0022 Dual Limb High Flow Nasal Cannula 5.0mm 4 HFN-0023 Dual Limb High Flow Nasal Cannula 6.0mm HFN-0024 Dual Limb High Flow Nasal Cannula 7.0mm HFN-0006 Infant nasal cannula OD 3.5mm, SD 7.0mm 5 HFN-0007 Infant nasal cannula OD 3.0mm, SD 6.0mm
7.3 Optional Table
Table 17. Optional Accessory Items Part No. 1 VF-2206 2 HF-PS-2900008 3 VD-311009 4 VH-P-VH-1161-003 5 HU-2555 F1009A-2 6 SF1002P+C007H
Contents Filter 36*30 Air filter Disposable straight straight connector Medical PVC tube Oxygen connector(Green) connector(Green) Adult Finger Clip SPO2 Sensor SpO2 sensor for Neonate silicone wrap type+SpO2 Ext-Cable
39 Ref. HF-PS-2900213 Rev. J
7.4 USB storage disc instruction for use
Storage indicator USB insertion position Notes: 1. When using the USB storage disc, please follow the instruction of HF-2900D technical manual to calibrate calibrat e the time of the device to reduce time error of the recorded event. 2. When inserting the USB storage disc, please check if the stora storage ge indicator on HF-2900D panel is lit. a. Indicator constant light: means HF-2900D and USB disc connect successfully. successfully. b. Indicator flash：when it flashes every 10 seconds, it means that the data of HF-2900D is accessing into the USB disc. (The status of USB indicator should flash simultaneously.) 3. It is suggested that when the first time use the USB, take it down after installing for about 5 minutes and use the PC to check if the data is successfully acc accessed. essed. a. When the first time using USB disc, it will generate the folder automatically. (Folder name is the year, ex: 2017.) b. The records generate at the same year will be placed in the folder for that year. year. c. File name is MMDD.CSV( MM：month；DD：day；.CSV：file extension；EX：0328.CSV is the event th file on March 28 .)。 d. It will generate generate only one file in one day. day. (EX：0328.CSV) A new record will be generated next day. (EX： 0329.CSV)。 e. It will be used 11Mbyte to record in 24 hours a day and it is required 4G capacities to continuously record for one year. 4. Software that can read the text file such as Notepad, Excel, etc. ※ Notes
1. Please use the USB disc that has been formatted by FAT32 and scanned by magnetic zone. 2. Please regularly back-up data in the USB every month to avoid it loss. 3. The internal space of USB disc must be greater than 100Mbyte. When the USB disc is full, it may cause the device cannot read normally and make the device determine that it is abnormal abno rmal and shut down. 4. USB disc is not including in the system standard accessories. If there is any malfunction like unable to write into the disc, it will not be including in GGM service and warran warranty ty.. 5. When the device is not in standby mode, the status of USB indicator should dark without flicker; during normal reading and writing, it should flash simultaneously with the panel p anel indicator. indicator. The rest of the status should be in dark.
40 Ref. HF-PS-2900213 Rev. J
8. Revision History Revision
Date
REV A
2014/06/12
REV B
2015/07/08
REV C C REV D REV E
2015/09/24 2016/02/22 2016/04/26
Description New Issue New warnings, new operating instruction, process and reformatting. New warnings of SPO2 Revise PEEP to P prox
Revise Annex B and §5.5 Main Screen Description Description 1.Added Symbol Definitio Definition n 2.Revise Pressure Measurement Range 3.Added §4.3 Table.4 Table.4 Nasal Nasal Cannula and Flow Flow
REV F
2016/07/15
4.Revise §5.4
Operating/Monitor Operating/Monit or Flow Chart
5.Added §5.7
Operating/Monitor Operating/M onitor Display Set Up Flow Chart Chart
6.Added §5.8
Function Set Up Display Description
7.Added 7. Added §5.9
Function Set Up Flow Chart
8.Added §5.10
Alarm System Description
9.Added §6.5 Accessories Replacing Schedule Schedule 10.Revise AnnexB.1~B.4 1.Added §1.3 Contraindications Contraindications Complication
REV G
2016/12/14
2.Revise §2.table2
Heart Rate replace to Pulse Rate
3.Added §2.table3
Gas Temperature range
4.Added §2.1.1
Maximum Operating pressure range
5.Revise 4.3 Chamber and tubing Installation Instructions 6.Added Note/Warning: N21 7.Added Troubleshooting B6
REV H
REV I
2017/07/03
2019/11/18
1.
Revise Warning: W3
2.
Revise Symbol definition of CE Notified Body
3.
Revise §4.3 table4 Flow Setting Range
4. 5.
Added §6.table13 and §7.table15 breathing circuit Revise Annex B-4 error code 1.05 / 2.02 / 2.03 delay time
1. Add warning W1 2.§2 Table 1 Revise heater wire maximum capacity 3.§2 Table 1 Revise adult and infant mode flow range 4.§2 Table 1 Add oxygen input range 5.§2 Table 1 Revise infant temperature control range 6.§2 Table2 Add alarm pressure range 7.Revise §4.2 Figure B2, Figure B8, and revise the description of Item b & g 8.Add Notes N21 9.Add Table 5 10.§4.3 Table 6 Add nasal cannula model, flow setting rang increase to 60L/min 11.Add Notes N28 12.Add Figure D3 13.Revome FiO2 Formula, combine the table 6 and table 7 to be a FiO2 comparison table 14. Revise §5.4 flow chart 15.Revise §5.8 and §5.9 to add \ D. \ D. Alarm Limit\4.Pprox 16.Revise 16. Revise table 12 17.Add nasal cannula models to §6.5 table 14, §7.2 table 16
41 Ref. HF-PS-2900213 Rev. J
REV J
2020/07/16
18. 18.Add Add Note 40~42 40~42 19.§7.3 Table 16 VD-311009 VD-311009 instead of HN-70059, HN-70059, F1009A-2 F1009A-2 instead of HF-PS-2900203 20.Add 20. Add §7.4 USB storage disc instruction for use 21.Delete alarm code 2.12 , and add the alarm code 2.22 and 2.23 1.Power on display version V3.000. 2.Revise Table 6. Nasal Cannula and Flow Comparison Chart 3.Revise Note N.27 4.Replace §5.4 Operation Flow Chart 5.§5.8/5.9 Add ”Others” 6.Add table 17.6 7.Annex B-2- Revise alarm code 2.11 to 1.05 8.Annex B-4- Revise alarm code 1.05~1.17 to 1.06~1.18 9. 9.Annex Annex B-4-Delete alarm code2.12 Pressure Line off 10.Annex B-6- Add alarm code 0.01/0.02
Annex A EMC Table Guidance and manufacturer’s declaration – electromagnetic emissions
The model HF-2900D is intended for use in the electromagnetic environment specified below. The customer or the user of the model HF-2900D should assure that it is used in such an environment.
Emissions test
Compliance
RF emissions
Group 1
CISPR 11
Electromagnetic environment – guidance The model HF-2900D uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Class A
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions IEC 61000-3-3
Complies
The model HF-2900D is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Recommended separation distances between portable and mobile RF communications equipment and the model HF-2900D HF -2900D The model HF-2900D is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the model HF-2900D can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model HF-2900D as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter (W)
Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz d = 1,2√P
80 MHz to 800 MHz d = 1,2√P
800 MHz to 2,5 GHz d = 2,3√P
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,2
1,2
2,3
10
3,8
3,8
7,3
100
12
12
23
For transmitters rated at a maximum output power not listed a above, bove, the recommended separation distance
d
in metres (m)
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. 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.
42 Ref. HF-PS-2900213 Rev. J
Guidance and manufacturer’s declaration – electromagnetic immunity
The model HF-2900D is intended for use in the electromagnetic environment specified below. The customer or the user of the model HF-2900D should assure that it is used in such an environment.
Immunity test
Electrostatic IEC 61000-4-2
IEC 60601 test level
Compliance level
discharge (ESD)
Electrical fast transient/burst
Electromagnetic environment – guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
supply lines
supply lines
input/output lines
input/output lines
Mains power quality should be that of a typical commercial or hospital environment.
IEC 61000-4-4
Surge IEC 61000-4-5
interruptions and voltage variations on power supply input lines IEC 61000-4-11
Power frequency (50/60 Hz) magnetic field
line(s)
line(s)
95 % dip in UT) for 0,5 cycle
95 % dip in UT) for 0,5 cycle
40 % UT (60 % dip in UT) for 5 cycles
40 % UT (60 % dip in UT) for 5 cycles
70 % UT (30 % dip in UT) for 25 cycles
70 % UT (30 % dip in UT) for 25 cycles
95 % dip in UT) for 5 sec
95 % dip in UT) for 5 sec
3 A/m
3 A/m
IEC 61000-4-8
Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the model HF-2900D requires continued operation during power mains interruptions, it is recommended that the model HF-2900D be powered from an uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level. Guidance and manufacturer’s declaration – electromagnetic immunity
The model HF-2900D is intended for use in the electromagnetic environment specified below. The customer or the user of the model HF-2900D should assure that it is used in such an environment.
Immunity
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the model HF-2900D, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
43 Ref. HF-PS-2900213 Rev. J
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
3 Vrms 150 kHz to 80 MHz
3 V/m 80 MHz to 2,5 GHz
3 V/m
3 V/m
d=
1,2√P
d=
1,2√P 80 MHz to 800 MHz
d=
2,3√P 800 MHz to 2,5 GHz
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 a electromagnetic site survey should be less than the compliance level in b each frequency range 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. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the model HF-2900D is used exceeds the applicable RF compliance level above, the model HF-2900D should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the model HF-2900D. b Over the frequency range 150 kHz to 80 MHz, field strengths should should be less than V/m.
Annex B. Troubleshooting B-1 Low Temperature Code Alarm Information
Possible cause
up. Temperature is Humidifier warming up. No lower than default Temperature probe not alarm alarm value. position. position.
Delay
