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Summary of Contents for Dräger Isolette C2000
- Page 1 Instructions for Use Isolette C2000 Infant Incubator WARNING To properly use this medical device, Software 3.n read and comply with these instruc- tions for use.
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Page 2: Typographical Conventions
Google Earth Google www.draeger.com/trademarks Trademarks owned by third-party manufacturers Trademark Trademark owner ® Actichlor Ecolab ® acryl-des Schülke & Mayr ® BruTab 6S Brulin ® Buraton Schülke & Mayr ® Descogen Antiseptica ® Dismozon Bode Chemie Instructions for Use Isolette C2000... -
Page 3: Safety Information Definitions
Service personnel Service personnel are persons who are responsible for the maintenance of the product. Service personnel must be trained in the mainte- nance of medical devices and install, reprocess, and maintain the product. Instructions for Use Isolette C2000... - Page 4 This page intentionally left blank Instructions for Use Isolette C2000...
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Page 5: Table Of Contents
Dräger Infinity Delta and Delta XL Isolette C2000 overview ....28 monitoring ......82 Oxygen system. - Page 6 Technical data......135 Isolette C2000 system ....136 Humidity system (option) .
- Page 7 Restrictions for use..... . 13 Product-specific safety information ..13 Instructions for Use Isolette C2000...
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Page 8: For Your Safety And That Of Your Patients
If other, incompatible accessories are used, there is a risk of patient injury due to medical device failure. Dräger recommends that the medical device is only used together with accessories listed in the current list of accessories. Instructions for Use Isolette C2000... -
Page 9: Sterile Accessories
– IEC 60601-1-8 Medical Electrical Equipment Part 1-8: Gen- eral requirements for basic safety Collateral standard: Alarm systems - Gen- eral requirements, tests, and guidance for alarm systems in medical electrical equip- ment and medical electrical systems Instructions for Use Isolette C2000... -
Page 10: Patient Safety
Patient monitoring The user of the medical device is responsible for choosing a suitable patient monitoring system that provides appropriate information on medical device performance and patient condition. Instructions for Use Isolette C2000... -
Page 11: Functional Safety
WARNING Risk of malfunction Unauthorized modifications to the medical device may lead to malfunctions. This medical device must not be modified without the permission of Dräger. Instructions for Use Isolette C2000... -
Page 12: Electromagnetic Compatibility (Emc)
Observe the fol- device. Make sure that there is a safe connection lowing section: "Electromagnetic environ- to the basic device. ment" (page 140). Strictly observe instructions for use and assembly instructions. Instructions for Use Isolette C2000... -
Page 13: Product-Specific Safety Information
Risk of electric shock ply mains with protective earth (protective The potential for electrical shock exists with ground). electrical equipment. Establish policies and procedures to educate your staff on the risks associated with electrical equipment. Instructions for Use Isolette C2000... - Page 14 Risk of injury or equipment damage The equipment shall not be used adjacent to other devices unless verification of normal operation in the configuration in which it is to be used can be achieved. Instructions for Use Isolette C2000...
- Page 15 If it is necessary to administer oxygen in an Disconnect the incubator from the hospital emergency, notify the attending physician oxygen source when oxygen is not in use. immediately. Noncompliance may result in death or serious injury. Instructions for Use Isolette C2000...
- Page 16 If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment. WARNING Risk of death or serious injury Use of anesthetic agents can interfere with oxygen monitor accuracy. Instructions for Use Isolette C2000...
- Page 17 WARNING Risk of death or serious injury To avoid overheating the infant due to direct radiation, do not position the incubator in direct sunlight or under other sources of radi- ant heat. Instructions for Use Isolette C2000...
- Page 18 Always push or pull the incubator forward or backward in a straight line along the length of To prevent possible trip and fall hazards, the stand (from the ends). always properly secure the power cable. Instructions for Use Isolette C2000...
- Page 19 – Use all cleaning products as recom- fected with pathogens. Disinfect and clean the mended by their respective manufactur- device thoroughly before using it for the first ers. time, and then once a week and every time the patient changes. Instructions for Use Isolette C2000...
- Page 20 – Unplug the device from its power source before cleaning or maintenance. WARNING Risk of shock or device failure Penetrating liquid may cause the following: damage to the device, electric shock, device malfunctions. – Ensure that no liquid penetrates the device. Instructions for Use Isolette C2000...
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Page 21: Application
Environment of use ....22 Indications/contraindications ... . 22 Instructions for Use Isolette C2000... -
Page 22: Intended Use
(optional), and humidity (optional). Environment of use The Isolette C2000 infant incubator can be used in tal Intensive Care Unit (NICU), Special Baby Care any department of the hospital that provides neona- Unit, Step Down Nursery, Newborn Nursery, and tal and infant care, including all levels of the Neona- Pediatrics. -
Page 23: Overview
Sensor module ......27 Isolette C2000 overview ....28 Oxygen system . -
Page 24: Front View
L Castor wheels (with brakes) E Access panel M Incubator AC power cable receptacle F Screen N Humidity reservoir (optional) G Front panel of controller O Trendelenburg bed-tilt knob H Serial port P Utility shelf (optional) Instructions for Use Isolette C2000... -
Page 25: Rear View
Overview Rear view A Type plate G AC power cable receptacle B Oxygen inlet H Air intake filter C Cylinder holder (optional) D Cable wrap E Fuse holder F Main On/Off power switch Instructions for Use Isolette C2000... -
Page 26: Right Side View
Overview Right side view A Sensor module B Iris port (optional) C Hood release knob D Controller/sensor module interface connector E Push/pull handle F Tubing grommets Instructions for Use Isolette C2000... -
Page 27: Sensor Module
Top View Bottom View A Skin 2 probe connector E Controller interface cable F Air, temperature, and humidity sensor housing B Skin 1 probe connector G Oxygen sensor housing C Alarm indicator D Scale connector Instructions for Use Isolette C2000... -
Page 28: Isolette C2000 Overview
Overview Isolette C2000 overview The Isolette C2000 infant incubator is a modular (0° to 12°). The incubator hood and shell assembly controller-based incubator that enables simultane- is mounted on a cabinet stand that provides conve- ous control of temperature, oxygen (optional), and nient storage. -
Page 29: Humidity System (Option)
Trend/Alarm window. System prompts are displayed in the Trend/Alarm window during the weighing procedure. Non-OIML/NAWI scales The Weight soft key allows for repeated reweigh- ing of the infant after the weighing routine has been initiated. Instructions for Use Isolette C2000... -
Page 30: Functional Description
(98.6°F) to 38.0°C (100.4°F). enable the user to select the desired Air or Skin mode. In either mode of operation, the heater output is proportional to the amount of heat required to main- tain the desired temperature. Instructions for Use Isolette C2000... -
Page 31: External Devices
WARNING Risk of death or serious injury Devices connecting to the serial port must be compliant with EN 60601-1-2, the EMC require- ment for Medical Devices. Instructions for Use Isolette C2000... -
Page 32: Abbreviations
Liquid crystal display L/min Liters per minute Medical Information Bus NAWI Non-Automatic Weighing Instru- ment OIML Organisation Internationale de Métrologie Légale (International Organization of Legal Metrology) Relative humidity UMDNS Universal Medical Device Nomen- clature System Instructions for Use Isolette C2000... -
Page 33: Symbols
Electromagnetic interference Power Failure alarm Communication port Power On Access panel open indicator (dis- played on screen) Power Off Lift Baby prompt to lift the infant from the bed (displayed on screen during the zeroing routine) Instructions for Use Isolette C2000... - Page 34 Level indicator mounted on the scale (OIML scale only) Keypad lock Alarm Audio Paused/Reset key Do not reuse Maximum water level Lot number Date of manufacture Do not discard with regular waste Instructions for Use Isolette C2000...
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Page 35: Technical Definitions
10 cm (4 in) above the mattress, surface differs from the average incubator temperature at incubator temperature equilibrium. Temperature variation The variation of the incubator temperature that will be observed over a one hour (stability) period after steady temperature condition has been reached. Instructions for Use Isolette C2000... - Page 36 This page intentionally left blank Instructions for Use Isolette C2000...
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Page 37: Operating Concept
Additional soft keys..... . 42 LED indicators ......42 Instructions for Use Isolette C2000... -
Page 38: Front Panel Of Controller
A A screen displaying all patient and system infor- mation in numeric and graphic form B Keys with variable functions (referred to as “soft keys” in this manual) C Fixed-function keys (referred to as “hard keys” in this manual) D LED indicators Instructions for Use Isolette C2000... -
Page 39: Screen
Additional trend displays are also available wheel is displayed in the upper right-hand cor- when the device is equipped with any of the fol- ner of the Humidity window. lowing: Servo Oxygen Control System, Humid- ity System, and Weighing System. Instructions for Use Isolette C2000... -
Page 40: Hard Keys
15 seconds of inactivity, the keypad locks and the user to select settings in the various dis- the Keypad Lock LED illuminates to indicate plays and the System Configuration menu. that the keys are locked. Instructions for Use Isolette C2000... -
Page 41: Soft Keys
The following soft keys are available at Display 1: A Air - selects the Air mode B Skin - selects the Skin mode C Humidity (optional) - selects the humidity dis- play D Oxygen (optional) - selects the oxygen display Instructions for Use Isolette C2000... -
Page 42: Led Indicators
37 °C (98.6 °F) or higher. In addition, there is a yellow LED located on the sensor module that illuminates to indicate that an alarm is in progress (see "Sensor module" on page 27). Instructions for Use Isolette C2000... -
Page 43: Assembly
(optional) ..... . . 51 Installing the breathing hose holder (accessory) ......53 Instructions for Use Isolette C2000... -
Page 44: Unpackaging
Assembly and functional checkout must be performed by service personnel. After the device is assembled and before it is placed into service, perform the functional checkout procedure on page 57. Instructions for Use Isolette C2000... -
Page 45: Attaching Accessories
WARNING Risk of death or serious injury The utility shelf and IV pole assembly are labeled for acceptable weights. Do not exceed these weight limitations. Instructions for Use Isolette C2000... -
Page 46: Installing The Weighing System (Accessory)
8 To ensure proper operation, perform the scale functional checkout (see "Weighing system functional checkout (accessory)" on page 64). WARNING Risk of death or serious injury Use cable management clips to avoid infant entanglement and possible injury. Instructions for Use Isolette C2000... -
Page 47: Oiml/Nawi Scale Assembly
Secure the scale cable to the incubator end wall using the cable clips provided on the inside of the incubator wall. Loop the cable at the lower clip. Instructions for Use Isolette C2000... -
Page 48: Installing The Humidity System (Option)
On factory installed systems, install the humidity reservoir: 1 Mount the reservoir and reservoir lid on the humidity tray. 2 Insert the humidity tray in the shell, and lock the handle. Instructions for Use Isolette C2000... -
Page 49: Installing The Servo Oxygen Control System
2 Ensure that the incubator On/Off switch is turned off. 3 Unplug the sensor module cable from the shell. 4 If present, unplug the scale cable and any skin probe cables from the sensor module. Instructions for Use Isolette C2000... - Page 50 11 Reinstall the sensor module in the hood, and be installed below the sensor module. If the position it in the normal (innermost) position. Oxygen Calibration Level is 21%, the slide lock fixture (without hose barb) must be installed below the sensor module. Instructions for Use Isolette C2000...
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Page 51: Installing The 100% Oxygen Calibration Fixture (Optional)
O-ring, which is coated with a lubricant. The Make sure that the brass connector (C) is facing O-ring could possibly become loose during ship- the rear of the incubator and the wording on the ping. label (D) is properly displayed. Instructions for Use Isolette C2000... - Page 52 10 Install the sensor module assembly in the hood assembly. NOTE When the slide lock and 100% calibration fixture are properly installed, the slide lock moves up and down smoothly. 11 Select the 100% calibration level (see "System configuration menu" on page 94). Instructions for Use Isolette C2000...
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Page 53: Installing The Breathing Hose Holder
NOTE When adjusting the breathing hose holder, make sure that it does not interfere with the scale (if installed) to allow for correct weight measure- ments. Instructions for Use Isolette C2000... - Page 54 This page intentionally left blank Instructions for Use Isolette C2000...
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Page 55: Getting Started
(accessory) ......64 Wheel lock functional checkout ... . 65 Instructions for Use Isolette C2000... -
Page 56: System Start-Up
(A) under the incubator shell assembly. 5 Locate the On/off switch (D) under the incubator shell assembly, and switch on the incubator. 2 Plug the stand power cable into an appropriate AC power source. Instructions for Use Isolette C2000... -
Page 57: Functional Checkout Procedure
NOTE For devices equipped with accessories, remove any accessories that interfere with the checkout procedure, and replace when completed. Instructions for Use Isolette C2000... - Page 58 Place the skin probe 10 cm (4 in) above the center of the bed. Press the Audio Paused/Reset key. The acoustic alarm signal silences for 5 minutes. Set the skin set temperature to 35 °C (95 °F). Instructions for Use Isolette C2000...
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Page 59: Hood/Shell Functional Checkout
Use the Down Arrow key to decrease the screen intensity 3 levels. Repeat steps for the rear access panel. CAUTION Risk of injury Both locking knobs must be fully engaged to avoid accidental opening of the panels. Instructions for Use Isolette C2000... - Page 60 – Rotate the locking knobs and open the front or rear access panel. – Reconnect the weighing scale cable to the sensor module. – Close the access panel, and rotate both latches until they are fully engaged. Instructions for Use Isolette C2000...
- Page 61 Check that the bed is level. If installed, check that the cuff is properly placed on the gasket. When installed cor- rectly, there is a small opening in the center of the cuff. Instructions for Use Isolette C2000...
- Page 62 Introduce a carefully measured 9 L/min of oxygen into the oxygen input connector (C) labeled O2 INLET. Using a calibrated oxygen monitor, check the oxygen level within the hood. Instructions for Use Isolette C2000...
- Page 63 Close the front access panel, and rotate When the sensor module lock is in the up both latches until they are fully engaged. position, check that the sensor module is locked securely in place. Instructions for Use Isolette C2000...
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Page 64: Servo Oxygen Control Module Functional Checkout (Option)
8 Verify that when the Weight Sample bar stops center of the bed. searching, or the bar is filled, a beep sounds and the weight is locked and displayed in the 3 Pre-warm the incubator in Air mode to 35.0°C Trend/Alarm window. (95.0°F). Instructions for Use Isolette C2000... -
Page 65: Wheel Lock Functional Checkout
3 Select Display 2, and press the Weight soft key. The weight screen is displayed. 4 If necessary, remove any objects from the bed before pressing the ->0/T<- soft key (see "Soft keys" on page 41). 5 Press the ->0/T<- soft key twice. Instructions for Use Isolette C2000... - Page 66 This page intentionally left blank Instructions for Use Isolette C2000...
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Page 67: Operation
OIML/NAWI scale calibration ....85 System shut-down ..... 86 Instructions for Use Isolette C2000... -
Page 68: Setting The Temperature
The screen changes to the temperature display patient compartment at the front and rear of the with new soft key labels and a border around the incubator is higher than the typical incubator air current temperature set point. temperature. Instructions for Use Isolette C2000... - Page 69 37.0 °C (98.6 °F) to 39.0 °C (102.2 °F) in 0.1° increments. 5 To lock the keypad, press the Keypad Lock (D) key. NOTE Once stabilized, the incubator temperature stays within 0.5 °C of the set temperature. Instructions for Use Isolette C2000...
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Page 70: Skin Mode
The screen changes to the temperature display with new soft key labels and a border around the current temperature set point. 3 Attach the skin probe to the infant (see "Skin probe attachment" on page 71). Instructions for Use Isolette C2000... -
Page 71: Single Or Dual Temperature Monitoring
Remove Skin2 Probe alarm is activated. 2 Before the probe is placed on the skin, thor- oughly clean and dry the skin area where the probe is to be placed. Instructions for Use Isolette C2000... - Page 72 0.5°C of the set temperature. 6 Check the condition of the infant at least every 15 minutes for correct sensor attachment, and feel the skin of the infant for signs of overheat- ing. Instructions for Use Isolette C2000...
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Page 73: Setting The Humidity (Option)
This can be minimized or eliminated if desired by changing the set RH % to a lower humidity setting. NOTE Check the water level in the humidity reservoir twice a day. The screen changes to the humidity display with new soft key labels. Instructions for Use Isolette C2000... -
Page 74: Setting The Humidity Control Set Point
If no keys are pressed within 15 seconds of mak- ing any selection, the screen automatically reverts to the previous display. 1 Activate the humidity system (see "Turning the humidity mode On/Off" on page 73). Instructions for Use Isolette C2000... -
Page 75: Setting The Servo Control Oxygen (Option)
The guide is valid only for manual control oxygen usage. The screen changes to the Oxygen display with new soft key labels. Instructions for Use Isolette C2000... -
Page 76: Setting The Oxygen Control Set Point
1 Activate the Oxygen mode (see "Turning the oxygen mode On/Off" on page 75). NOTE If no keys are pressed within 15 seconds of mak- ing any selection, the screen automatically reverts to the previous display. Instructions for Use Isolette C2000... -
Page 77: Manual Control Oxygen Usage (Option)
4 Close the access panel, and ensure that the Before placing the infant in the incubator, pre- locking knobs are fully engaged. warm the incubator to the temperature pre- scribed by the attending physician, or according to nursing protocol. Instructions for Use Isolette C2000... -
Page 78: Scale Measurements (Accessory)
Risk of death or serious injury For infant safety, do not leave the infant unat- tended when the access panel is open. NOTE The bed should be level, i.e., not in the Trendelen- burg or Reverse Trendelenburg position. Instructions for Use Isolette C2000... - Page 79 24- hour period. Subsequent trend data for the remain- ing 6 days represent the difference between the last stored weight, within a 24-hour period, and the baseline weight measurement. Instructions for Use Isolette C2000...
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Page 80: Oiml/Nawi Scale Measurements
Subsequent trend data for the remain- ing 6 days represent the difference between the last stored weight, within a 24-hour period, and the baseline weight measurement. 8 To return to Display 2, press the Home soft key. Instructions for Use Isolette C2000... -
Page 81: X-Ray Tray Usage
9 When the X-ray is completed, repeat steps 1 and 2. 10 Remove the X-ray cassette from the tray, and return the tray. 11 Close the access panel, and ensure that the locking knobs are fully engaged. Instructions for Use Isolette C2000... -
Page 82: Dräger Infinity Delta And Delta Xl Monitoring
VueLink software does not have touch-screen 4 While pressing the Audio Paused/Reset key, capability. switch on the incubator On/Off switch to enter the System Set Up menu. 5 Using the Display Selection key, scroll down to the VueLink software option. Instructions for Use Isolette C2000... -
Page 83: Oxygen Sensor Calibration (Option)
(see "System configuration menu" on page 94). 9 If the message Cal Fail is displayed, refer to "In case of calibration failure" on page 84. 2 If required, configure the oxygen calibration level setting for 21%. Instructions for Use Isolette C2000... -
Page 84: Oxygen Sensor Calibration To 100% Oxygen
Cal Fail vs. room air must all agree. message. To withdraw the module, pull down the lock (A) and slide out the module (B) from the hood until it stops. Instructions for Use Isolette C2000... -
Page 85: Scale Calibration (Accessory)
DrägerService for further information. NOTE If the 5-kg weight is not placed on the center of the bed within 12 seconds after the 5-kg symbol is displayed, the Cal Failed message is displayed. Instructions for Use Isolette C2000... -
Page 86: System Shut-Down
2 Disconnect the incubator from the hospital oxy- gen source. 3 Switch off the On/Off switch on the incubator shell to power down the incubator. 4 Switch off the main On/Off switch on the back of the cabinet stand. Instructions for Use Isolette C2000... -
Page 87: Alarms
To initiate a procedural silence: ... . 90 To disable audio alarms:....90 Instructions for Use Isolette C2000... -
Page 88: Safety Information
1 meter from the front panel of the controller. Alarm priority Isolette C2000 alarms are organized into one of 2 Medium – Alarm that requires prompt categories based on the urgency of the alarm: action to avert risk –... -
Page 89: Alarm Indication
A total of 6 messages can require attention or correction. be presented in the Trend/Alarm window. For a complete list of Isolette C2000 alarm mes- The Isolette C2000 automatically delays certain sages, see "Alarm messages" on page 98. -
Page 90: Disabling The Alarm Tone Sequence
– There is no acoustic alarm signal, unless there is a High Temperature, Probe Failure, or Air Flow alarm. – The alarm message and the measured value are displayed. – The LED on the Audio Paused/Reset key (B) illuminates. Instructions for Use Isolette C2000... -
Page 91: Trends
Trends Trends Trend display ......92 Instructions for Use Isolette C2000... -
Page 92: Trend Display
Display soft key (C) repeatedly until the desired setting is shown: Air temperature Skin temperature 1 Skin temperature 2 Heater power % Oxygen (optional) Humidity (optional) Weight (optional) Instructions for Use Isolette C2000... -
Page 93: Configuration
System configuration menu ... . . 94 Default Settings ......94 Instructions for Use Isolette C2000... -
Page 94: System Configuration Menu
0 ft ments of 2000 ft) VueLink™ Yes/No Display Color White on blue/Yellow on black White on blue 1) For OIML devices, only kg units shall be displayed. 2) Used for 21% oxygen calibration offset. Instructions for Use Isolette C2000... - Page 95 Press the Diag Info soft key (F) to display a system information screen Press the Page 2 soft key (G) to access addi- tional configuration menu options 6 Press the Audio Paused/Reset key (A) to exit the System Configuration menu. Instructions for Use Isolette C2000...
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Page 97: Problem Solving
..... . . 107 System prompt messages ....108 Instructions for Use Isolette C2000... -
Page 98: Alarm Messages
Problem solving Alarm messages The Isolette C2000 displays alarm messages in the In the following table, the alarm messages are Trend/Alarm window. If two or more system alarms listed in alphabetical order. If an alarm occurs, the occur simultaneously, or one after the other, the table helps to identify causes and remedies. - Page 99 Switch off the incubator and then turn it on again. If the alarm still contin- ues, replace the sensor module. If the alarm persists, remove it from service. Instructions for Use Isolette C2000...
- Page 100 Configuration menu (see "System configuration menu" on page 94). Medium Stuck Key There is a malfunction of the Switch off the incubator and hard keys on the front panel remove it from service. of the controller. Instructions for Use Isolette C2000...
- Page 101 15 minutes) Skin1 probe) is > 38.0°C ± Switch off external heat 0.2°C when the Override sources. mode is not active, or > 39.0°C ± 0.2°C when the > 37 °C mode of operation is active. Instructions for Use Isolette C2000...
- Page 102 (for a maximum of temperature; the skin probe 30 minutes)) is not properly secured to (Alarm can be silenced for skin (in Skin mode only). 15 minutes and can also be set to a 15-minute procedural silence) Instructions for Use Isolette C2000...
- Page 103 (Alarm is delayed for 50 seconds Skin mode) is mechanically after the alarm condition occurs) connected but electrically (Alarm can be silenced for open or short-circuited. The 5 minutes) associated monitoring dis- play shows "----". Instructions for Use Isolette C2000...
- Page 104 A tubing grommet is not Check the installation of the properly installed. tubing grommet. Gaps in hand port gaskets Check gaskets for proper fit. If the alarm persists, switch off the incubator and remove it from service. Instructions for Use Isolette C2000...
- Page 105 (Alarm is delayed for 50 seconds 3%. As a result, the oxygen calibration (option)" after the alarm condition occurs) flow into the system is inter- on page 83). (Alarm can be silenced for rupted. 4 minutes) Instructions for Use Isolette C2000...
- Page 106 (Alarm is delayed for 1 minute after the alarm condition occurs) Slide In Sensor Calibration is completed but Slide the oxygen sensor the oxygen sensor module module into the hood. was not returned to the hood position. Instructions for Use Isolette C2000...
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Page 107: Problems/Alarm Conditions Without Alarm Messages
(see "Fuse replacement" on page 129). No data is displayed on Internal controller failure. Switch off the incubator and remove it screen at system start-up from service. (only static/noise). Instructions for Use Isolette C2000... -
Page 108: System Prompt Messages
0.8 °C; or if in either Air or Skin mode, the Skin2 probe is < 16.9 °C. Clear Mattress A scale calibration is attempted, and Remove all items from the bed mat- there is >1 Kg on the bed mattress. tress. Instructions for Use Isolette C2000... - Page 109 Slide Out Sensor This message is displayed when the Slide the sensor module out to the cal- Cal soft key is pressed, but the sensor ibration position. module is not pulled out into the cali- bration position. Instructions for Use Isolette C2000...
- Page 110 Zeroing Failed This message is displayed when an Remove additional weight and retry additional weight on the bed exceeds zeroing. If it fails again, remove scale 4000 g when zeroing during infant from service. weight. Instructions for Use Isolette C2000...
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Page 111: Cleaning, Disinfection, And Sterilization
Assembling parts ..... . 120 Before reuse on patients ....122 Instructions for Use Isolette C2000... -
Page 112: Safety Information
Do not autoclave the device, except for compo- separation is necessary, contact DrägerService. nents specifically identified in this chapter. CAUTION Risk of injury or equipment damage Before disassembling the hood and shell assem- blies, remove accessories mounted to device. Instructions for Use Isolette C2000... -
Page 113: Disassembly
The heater can be sufficiently hot to cause burns. Avoid removing or touching the heater until the device has been switched off for at least 45 minutes. 2 Remove the heater radiator (E). 3 Pull the impeller (F) off the motor shaft. Instructions for Use Isolette C2000... -
Page 114: Reprocessing Procedures
At the time of testing, the follow- – Uncritical medical devices: surfaces accessible ing procedures and agents showed good material to users and patients, e.g., device surfaces, compatibility and effectiveness: cables Uncritical medical devices Manual disinfection and simultaneous cleaning: Instructions for Use Isolette C2000... - Page 115 For US markets, use an intermediate level clean- have verified at least the following spectra of activ- ers/disinfectant registered by the Environmental ity: Protection Agency (EPA). – Bactericidal – Yeasticidal – Virucidal or virucidal against enveloped viruses Instructions for Use Isolette C2000...
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Page 116: Uncritical Medical Devices
3 After the contact time has elapsed, remove dis- infectant residues. Controller, shell, and stand CAUTION Risk of injury or equipment damage When cleaning the interior of the incubator shell, prevent liquids from entering the motor shaft opening. Instructions for Use Isolette C2000... - Page 117 1 Remove any lint build-up on the heater radiator and fan impeller. 2 Wipe the heater assembly with surface disinfec- tant. Do not immerse the heater assembly in liquid. Instructions for Use Isolette C2000...
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Page 118: Visual Inspection
Even reusable accessories have a limited service life, e.g., disinfectant residues can corrode the material during autoclaving. External signs of wear can occur, e.g., cracks, deformations, dis- colorations, or peeling. If there are external signs of wear, exchange affected accessories. Instructions for Use Isolette C2000... -
Page 119: Reprocessing List
X-ray tray Between patients Main deck Between patients Scale Between patients Bed-tilt bars Between patients 1) For cleaning recommendations for the SoftBed mattress and for reusable skin temperature probes, consult their manufac- turer instructions for use. Instructions for Use Isolette C2000... -
Page 120: Assembling Parts
4 Install the main deck. 5 Install the bed-tilt bars on the main deck. 6 Install the bed, x-ray tray, and scale (if installed). Instructions for Use Isolette C2000... - Page 121 19 If required, reattach any accessories previously 10 Install the tubing grommets into the front and removed from the device. rear edges of each side of the hood. NOTE Replace tubing grommets if distorted or torn. Instructions for Use Isolette C2000...
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Page 122: Before Reuse On Patients
Cleaning, disinfection, and sterilization Before reuse on patients Perform a complete functional checkout before returning the device to service. Refer to "Functional checkout procedure" on page 57. Instructions for Use Isolette C2000... -
Page 123: Maintenance
Fan replacement (controller) ....131 Repair ....... 131 Instructions for Use Isolette C2000... -
Page 124: Overview
"Functional checkout procedure" on page 57 and perform the function checks. NOTE Users and service personnel should routinely inspect the patient compartment for signs of break- age and should replace assemblies before placing the incubator into service. Instructions for Use Isolette C2000... -
Page 125: Inspection
3 Perform an inspection of the following features: – Hand ports – Hood – Unauthorized probes or modifications to equipment – Castors and movement of the device 4 Check that the device combination is in good condition: Instructions for Use Isolette C2000... -
Page 126: Preventive Maintenance
There is a power entry module that has fuses on both of the mains lines. It also has a double pole single throw (DPST) switch which isolates the de- vice from the mains when it is switched to the "OFF" position. Instructions for Use Isolette C2000... - Page 127 Probe covers Users and service personnel sensors Service personnel Latch, heat shield Service personnel solenoid valve Service personnel 3 year service Service personnel kit, Isolette Fan in sensor module Service personnel pressure reducer Service personnel Instructions for Use Isolette C2000...
- Page 128 5) Measuring accuracy depends on local gravity, as determined by altitude and latitude. The specified accuracy is only appli- cable if the scales have been calibrated at the installation site. Instructions for Use Isolette C2000...
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Page 129: Maintenance Instructions
3 Install the air intake filter cover, and tighten the 2 thumbscrews. O2 solenoid replacement 1 Remove oxygen servo assembly. 2 Remove O2 solenoid. 3 Replace O2 solenoid. 4 Install the oxygen servo assembly. 5 Perform the functional checkout procedure (see page 57). Instructions for Use Isolette C2000... -
Page 130: O2 Pressure Reducer Replacement
2 Replace heat shield latch. module seam along that seam. 3 Open the sensor module. 4 Partially remove the main PCB, and disconnect the ribbon cable. 5 Remove the connector PCB (including fan) from the sensor module. Instructions for Use Isolette C2000... -
Page 131: Repair
7 Reassemble by reversing the order of disas- sembly. 8 Perform the functional checkout procedure (see page 57). Repair Dräger recommends that all repairs are carried out by DrägerService and that only authentic Dräger repair parts are used. Instructions for Use Isolette C2000... - Page 132 This page intentionally left blank Instructions for Use Isolette C2000...
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Page 133: Disposal
Disposal Disposal Disposing of the medical device..134 Instructions for Use Isolette C2000... -
Page 134: Disposing Of The Medical Device
Dräger on the Internet at www.drae- ger.com. Use the Search function with the keyword "WEEE" to find the relevant information. If access to Dräger's web site is not possible, contact the local Dräger organization. Instructions for Use Isolette C2000... -
Page 135: Technical Data
Technical data Isolette C2000 system ....136 Humidity system (option) ....138 Oxygen control system . -
Page 136: Isolette C2000 System
≤ 300 µA Chassis current leakage (100/120V) ≤ 500 µA Chassis current leakage (220/230V) Performance Air mode control temperature range 20.0°C (68.0°F) to 37.0°C (98.6°F) Air mode control override temperature range 37.0°C (98.6°F) to 39.0°C (102.2°F) Instructions for Use Isolette C2000... - Page 137 10 cm (4 in) above the mattress Carbon Dioxide (CO2) level < 0.5% (per EN60601-2-19, Clause 105) Operational Set point data retention power failures lasting <10 min Alarm sound level > 65 dB(A) 1) Applicable to open panel or ports. Instructions for Use Isolette C2000...
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Page 138: Humidity System (Option)
18% to 100% Oxygen control accuracy ± 2% of full scale Manual oxygen control system (option) Oxygen inlet pressure 40 psi to 150 psi (2.8 kg/cm to 10.5 kg/cm Oxygen inlet flow rate 30 L/min Instructions for Use Isolette C2000... -
Page 139: Non-Oiml/Nawi Weighing System
90 arc minute (1.5 degree) Weight display update rate 1 second Accessories Utility shelf assembly weight limitation: 11.4 kg (25 lb) IV pole assembly weight limitation: 5 kg (11 lb) Cylinder holder D and E size cylinders Instructions for Use Isolette C2000... -
Page 140: Emc Declaration
(for which CISPR 11 class B is normally required), this equipment might not of- fer adequate protection to radio-frequency com- munication services. The user might need to take mitigation measures, such as relocating or re-ori- enting the equipment. Instructions for Use Isolette C2000... -
Page 141: Recommended Separation Distances From Wireless Communication Devices
Recommended separation distances from wireless communication devices To ensure that the functional integrity of this device is maintained, there must be a separation distance of at least 1.0 m (3.3 ft) between this device and wireless communication devices. Instructions for Use Isolette C2000... - Page 142 This page intentionally left blank Instructions for Use Isolette C2000...
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Page 143: List Of Accessories
Consumables ......144 Optional components....145 Instructions for Use Isolette C2000... -
Page 144: Accessories
Probe 5, large skin temperature, box of 10, YSI MU12551 Oxygen sensor kit MU24903* *should be installed by service personnel Consumables Description Part Number Air filter, replacement, 4 MU12504 Iris port sleeve, disposable, 100 MU03876 Hand port cuff, disposable, 100 MU06570 Instructions for Use Isolette C2000... -
Page 145: Optional Components
Straps, utility shelf (2) MU14688 Breathing hose holder kit MU18660 Kit, HFV access door with grommets MU18916 Cabinet door assembly MU26097* Grommet MU12609 Humidity reservoir assembly, CPC fitting with cup MU17191 *should be installed by service personnel Instructions for Use Isolette C2000... - Page 146 This page intentionally left blank Instructions for Use Isolette C2000...
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Page 147: Index
....71 manual control oxygen ....77 Instructions for Use Isolette C2000... - Page 148 ..... 94 system prompt messages ....108 Instructions for Use Isolette C2000...
- Page 149 This page intentionally left blank Instructions for Use Isolette C2000...
- Page 150 These instructions for use only apply to Isolette C2000 Infant Incubator with the Serial No.: Without Serial No. filled in by Dräger, these instructions for use are provided for general information only and do not apply to a specific medical device.
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