Summary of Contents for CareFusion Carefusion LE200 LC
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Carefusion LE200 LC original instruction for use treadmill h/p/cosmos ® 150/50 LC IMPORTANT! READ CAREFULLY BEFORE USE! KEEP FOR FUTURE REFERENCE! firmware version: v3.03.x article number: cos105000-2016-00 en run ahead of time ®...
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These instructions for use are only valid for the original configuration of the first delivery of the devices pictured below. If the device has been changed, please refer to the latest version of this document, available at: www.h-p-cosmos.com Product family: treadmill h/p/cosmos 150/50 LC Models: pluto | Carefusion LE200 LC ® (cos30027va08) page 2 cos105000-2016-00 en...
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Dear customer, Thank you for choosing this premium device. Since its establishment in 1988, h/p/cosmos has strongly influenced sports, athletics, ® ergometry, rehabilitation, and science through the development and distribution of new products, software, system solutions, and application methodologies. During this time the company, based in Traunstein, Germany, has developed into THE German specialist for manufacturing treadmill ergometers and systems for fitness, sports, sports science, sports medicine, athletics, biomechanics, medicine, rehabilitation, therapy, ergometry, performance diagnostics, and scientific research.
1 Symbols and Labels 1.1 Symbols used (general) Illustraion Description Reference CE sign, proof that the essential requirements (according to medical device directive (here with number of notified body) were met 93/42/EEC) General warning (danger, warning or caution statements) (acc. to DIN EN ISO 7010 W001) Warning of obstacles (stumbling) (acc.
1.2 Symbols used (transport) Illustraion Description Reference Fragile, Handle with care (acc. to ISO7000-0621) This way up (acc. to ISO7000-0623) Keep dry (acc. to ISO7000-0626) Centre of gravity (acc. to ISO7000-0627) Temperature limitations (acc. to ISO7000-0632) Do not stack (acc. to ISO7000-2402) page 8 cos105000-2016-00 en...
3 Intended Use 3.1 Intended use h/p/cosmos medical treadmills are intended for walking or running in place for Recreational fitness training ❚ Gait training (with or without body weight support) ❚ h/p/cosmos medical treadmills can be used in combination with external devices for walking or running in place as Loading devices for neuromuscular and biomechanical measurements (e.g.
4 Safety h/p/cosmos medical treadmills may be operated with healthy subjects as well. For applications with healthy subjects, please apply the instructions for use for sports devices, available at www.h-p-cosmos.com 4.1 Safety information – Forbidden use Obey the following danger, warning and caution statements stricktly in order to prevent serious injury or death! For any medical treadmill application, a fall prevention device is prescribed and absolutely obligatory.
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Do not insert metal objects such as a pin or a wire into any gap or any outlet on the device. ❚ Do not touch the patient and external electrical devices at the same time. ❚ Always the latest command will be executed, regardless of whether it came via interface or from the UserTerminal during one of ❚...
4.2 Fall prevention devices A fall prevention device is the only effective way to protect the patient from falling. For any medical treadmill application, a fall prevention device is prescribed and absolutely obligatory. h/p/cosmos provides fall prevention devices in the form of a safety arch or a body weight support device (airwalk). It is up to the operator to use any other device that prevents the patient from falling and complies with IEC60601-1.
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Description Ilustration Tighten shoulder and chest straps. Use carabiner to connect safety harness with rope. Explain function to subject. Adjust the length of the rope in a way the patient has to maintain the correct position (see “position of patient and operator”).
4.3 Emergency dismount Patient is conscious and aware of danger. Patient grabs the handrails ❚ Patient jumps off the running belt onto the foot rails ❚ Operator / patient hits the emergency off ❚ Patient is conscious but not aware of danger. Patient stumbles and falls into fall prevention device.
4.4 Emergency off Do only use in case of emergency. Do not use as normal stop button. Do not stand on or enter the running deck when device is in elevation (running belt might slip through due to gravity). Operation Result Release Restart...
4.6 Unauthorized access See OP 40 … 44 in the User Options to lock the whole device or individual modes. 4.7 Residual risk / Side effects After risk reduction only 13 of more than 230 causes are in the "widely acceptable" region. In case fall prevention is not applied or not applied correctly, there are residual risks, such as falling of a person resulting in skin abrasions, bruises, fractures or in worst case even death.
5 Preparation Description Ilustration Perform daily inspection as described in “daily inspection”. Explain device and application to patient. Explain and apply fall prevention as described in “fall prevention”. Guide patient onto treadmill. Do not enter the device when running belt is rotating. ❚...
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Description Ilustration Apply pull-cord safety stop. (Attach clip to patients’ clothing.) Adjust the length of the rope so that the patient has to maintain the correct position (see “position of patient and operator”). page 21 cos105000-2016-00 en...
6 UserTerminal 6.1 Keys and displays Primary function Element Secondary functions Displays currently activated mode Displays current speed in m/min, km/h, m/s or mph (see LED)* Displays max. speed when selecting modes Displays covered distance in m, km or miles (see LED)* Displays elapsed time in minmin:ss or hh:minmin Displays duration when selecting profiles Displays current profile step / number (see...
6.2 Standard vs. “lt” devices Most h/p/cosmos treadmills are available as standard or “lt” (light) devices. “lt” devices have no UserTerminal (no display, no keyboard). Standard device “lt” device Control via Control via - UserTerminal - Software (see “accessories”) - Software (see “accessories”) - additional keyboard (see “accessories”) - additional keyboard (see “accessories”) - ECG, spirometry, etc.
6.3 Connection of external devices / Interfaces The back of the UserTerminal has RS232 interfaces. For USB-RS232 converter, see “accessories”. The person combining a medical device with any other device for the first time is creating a Medical Electrical System. Requirements for ME-Systems, see “creating systems”.
7 Position of Patient and Operator Position of patient (initial contact) 1a) Optimal position 40%, front 1b) Tolerated position 30%, middle running area 1c) Not tolerated position / buffer zone 30%, rear Intended position of operator The operator must be within reach of the emergency off at all times. If the operator is not able to reach the emergency off button at the UserTerminal (body height, obstacles, etc.), the operator must install an additional emergency stop within reach (see accessories).
8 Operation 8.1 General application procedure Description Illustration Disinfect the device (see “cleaning”). Disconnect the device and all accessories from mains power supply before cleaning or disinfection. Make sure… …the PE-cable is connected to electrical installation and device, …the device is directly plugged into the dedicated wall socket, …the device protection switch on the front of the device is switched on (light on),...
8.3 Manual mode Basic functions Buttons / displays Further information Device must be in “mode selection” Select “manual mode” with “+” or (one of the mode LEDs flashes) “-“ button To get there, cancel all other Selected mode flashes. activities by pressing the “stop”- button.
8.4 Profile mode The automatic modes must only be performed on the prescription of the medical doctor. ❚ Operator and patient have to be aware of automatic load changes during profile, cardio and test mode. ❚ Start and load changes within the automatic modes are indicated by acoustic signals (beep). Furthermore, the displays show the next load parameters (flashing).
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Basic functions Buttons / displays Further information Device must be in “mode selection” Select “profile mode” with “+” or “-“ (one of the mode LEDs flashes) button. To get there, cancel all other Selected mode flashes. activities by pressing the “stop”- button.
8.5 Cardio mode (optional) WARNING! Heart rate monitoring systems may be inaccurate. ❚ Incorrect or over exercising may result in serious injury or death. ❚ If you feel faint or dizzy stop exercising immediately and consult a medical doctor. ❚ Exclude overloading or overstressing of the patient.
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If the heart rate signal totally fails, an acoustic warning signal occurs and the heart rate display shows no value any more. Furthermore, the device reduces speed and elevation to 0 within one minute. For possibilities to interfere with an automatic program, see “interfere with an automatic program”. The treadmill adjusts speed and elevation according to following matrices.
8.6 Test mode WARNING! Heart rate monitoring systems may be inaccurate. ❚ Incorrect or over exercising may result in serious injury or death. ❚ If you feel faint or dizzy stop exercising immediately and consult a medical doctor. ❚ Exclude overloading or overstressing of the patient. ❚...
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Basic functions Buttons / displays Further information Following tests require further settings: Select test with “+” or “-“ 01 UKK walk test Confirm with “enter”. 02 Graded test The running belt starts automatically after countdown. 03 Conconi test 10 Ramp profile Terminate the operation with “stop”.
8.7 Interfere with automatic program Basic functions Buttons / displays Further information Profile / test mode: Only valid for current step. Alter speed Cardio mode: Press “+” or “-“. Reduce the speed with “-“ or exceed the max. speed with “+”; This sets a new max.
8.8 Pause function Reducing the speed with the “-“ key to 0.00 km/h, triggers the “pause” function. The running belt stops. The speed display shows “PAUS”. Pressing the “start” key, starts the running belt at the preset starting speed (default: 0.5 km/h). All values are maintained. Pressing the “+”...
8.9 Acceleration levels Start the use of the treadmill with slow walking, especially for beginners. ❚ There are seven acceleration / deceleration levels for any kind of operation. The acceleration levels are defined by the time it takes to accelerate from 0 km/h to maximum speed. Example: With acceleration level 3, it takes 33 seconds from 0 km/h to maximum speed (see table below).
8.10 User Options Basic functions Buttons / displays Further information Press “+”, “-“ and “stop” together for “speed “ display shows “OP 01”. at least 3 s. Select option with “+” or “-“ Confirm with “enter”. Adjust option with “+”or “-”. Confirm with “enter”.
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Table of User Options (details see chapter 17.4 “User Options (details)”) function Adjustable range (default setting) OP 01 Reset error messages. OP 02 Total distance (km) Report only OP 03 Total time (h), operation + stand-by Report only OP 04 Total time (h), operation only Report only OP 05...
9 Accessories / compatible devices Do not modify the device, configurations, accessories or software in any way. ❚ Do not connect any devices, accessories or software, not listed in “accessories / compatible devices”. ❚ Read and obey all instructions for use of all accessories and compatible devices. The list of accessories / compatible devices may vary.
10 Disinfection / Cleaning Disinfect the device before and after every treatment. ❚ Disconnect the device and all accessories from mains power supply before cleaning or disinfection. ❚ Description Illustration Disinfection − Unplug the device. − Apply some disinfectant to a cloth. −...
11 Maintenance Obey the maintenance intervals claimed in chapter “maintenance”. ❚ Obey the competences claimed in chapter “maintenance”. ❚ A second person has to be present during maintenance. ❚ In case of any visible or assumed defects or malfunctions (of the device, accessories, software, etc.), unplug device, exclude ❚...
Description Illustration Perform a functional check of all safety equipment: 5. Fall prevention 6. Pull cord safety stop 7. Emergency off button on UserTerminal 8. Further safety equipment If there is any visible or assumed defects or malfunctions, unplug device, exclude reconnection and call h/p/cosmos service personnel.
Description Illustration Start the running belt with 2 km/h and walk on the belt for 2 min. Vary the position in order to distribute the lubricant. Reset the OIL message (see OP01 in “User options”). 11.4 Adjustment of running belt Unmeant trapping hazards: Take off ties, scarfs or other clothes that may be trapped.
11.5 Issues for qualified service personnel All maintenance work that is not explained in detail, must not be performed by the operator. Safety inspections, installation and repair work, must also not be performed by the operator. This kind of work must be performed by h/p/cosmos service personnel according to the “h/p/cosmos service instructions”. The “h/p/cosmos service instructions”...
12 Troubleshooting 12.1 General troubleshooting In case of any visible or assumed defects or malfunctions (of the device, accessories, software, etc.), unplug device, exclude ❚ reconnection, mark clearly and inform h/p/cosmos service personnel via telephone and writing. In case of any visible or assumed wear and tear (of the device, accessories, labels, etc.), unplug device, exclude reconnection, ❚...
12.2 RS232 troubleshooting Problem Solution No connection via RS232 For connection to PC with h/p/cosmos software and most external devices use the included RS 232 interface connection cable [cos00097010034]. (wrong cable) No connection via RS232 Check cable and plugs for defects. (cable defect) Replace defective cable.
13 Technical data 13.1 UserTerminal Description Data Displays 6 seven-segment LCD displays, LED displays of mode and unit Keyboard 6-key keyboard film “lt” devices have no UserTerminal (no display, no keyboard). 13.2 Dimensions Description Data Device dimensions 2095 x 850 x 1310 mm (L x W x H) Running surface dimensions 1500 x 500 mm (L x W) Track access height...
13.6 Environmental conditions Operation Data Temperature 0 … 40° C Humidity 20 … 90%, without condensation Pressure 700 … 1060 hPa Altitude max. 3000 m, without pressurization (altitudes >1000m can cause minor loss of performance) Oxygen saturation <= 25% Exclude danger of explosions or inflammability. Exclude high voltage lines / devices in near vicinity. Transport &...
13.9 Classification Description Data MDD 93/42/EEC Notified body MDD 93/42/EEC Risk class active therapeutic device and active diagnostic device 60601-1 Protection against electric Class I, shock IEC 60601-1 Protection against harmful IP00 ingress of water or particulate matter IEC 60601-1 Mode of operation Continuous operation IEC 60601-1...
13.12 Voltage, Current, Performance Description Data Input voltage * 200 V - 240 V ~ (f: 50 – 60 Hz) Current input (long time) * 6.0 A Current input (momentary) * 13.5 A Energy consumption (long time) ≤ 1440 VA Energy consumption (momentary) ≤...
14 Liability and Warranty Following will cause loss of liability and warranty and may result in serious injury or death or damage to the device: Use other than explicitly mentioned as intended use ❚ Unauthorized maintenance or lack of maintenance, safety checks or repairs ❚...
17 Annex I 17.1 Installation This device must only be unpacked, transported and installed by h/p/cosmos service personnel (see maintenance). If the packaging has been damaged, please contact service@h-p-cosmos.com immediately. It is the customer’s responsibility to ensure the following conditions before the installation: There must be a separate power circuit for the device (dedicated line).
17.3 Instruction protocol, signatures By signing this protocol, the authorized h/p/cosmos service personnel and the customer confirm the receipt and understanding of all safety information, the performed instruction and commissioning according to the instruction protocol [cos15228-03]. The customer confirms the receipt of the listed devices including all accessories and options according to the h/p/cosmos delivery note. Disregard of safety information, intended or forbidden use, as well as unauthorized maintenance or lack of maintenance and regular safety checks may lead to injury or even death and can damage the device.
17.4 User Options (details) Option Description Comment / Display OP01 Reset (delete) error messages The required maintenance work must be performed before deleting error messages. The h/p/cosmos service department must be contacted before one of the service displays or error codes is deleted! Confirmation on display indicating "donE"...
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Option Description Comment / Display OP11 Scaling of the profiles in profile mode (not for shows: Scaling possibilities test mode) 0: No scaling (standard) 1: Scaling 1...6, which is shown in the profile mode on the INDEX display, refers to all parameters together (speed, elevation, time) 2: Scaling 1...6 refers to each parameter individually (speed, elevation, time) OP12...
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Option Description Comment / Display OP20 RS232 interface protocol: COM 1 indicates flashing: number of the RS232 interface protocol Do not connect any devices, accessories or reports: software, not listed in “accessories / compatible devices”. OFF = RS232 not active / no protocol / interface deactivated h/p/cosmos coscom v1, v2, v3 with baud rate 9600 bps (standard setting COM 1 and COM 2) printer protocol (serial printer or converter required)
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Option Description Comment / Display OP29 Standard acceleration and deceleration level for The selected acceleration and deceleration level is valid for control RS 232 interface and operation via RS232 interface. This option is very helpful if the peripheral equipment (e.g. ECG, ergospirometry, PC) does not offer a menu for acceleration and deceleration levels.
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Option Description Comment / Display OP48 Program step countdown OFF = The time display counts up each program step ON = The time display counts down each program step OP52 Output interval for printer protocol By entering a value between 0 and 100, the output interval is set in seconds for a printer directly connected to the treadmill.
18 Annex II (Pre- & self-defined tests) 18.1 UKK walk test UKK stands for Urho Kaleka Kekkonen, founder of the UKK Institute in Tampere, Finland. The UKK walk test is a fitness test, calculating the UKK Fitness Index based on the measured heart rate within a 2 km walk at max. walking speed.
18.2 Graded test Description Illustration (e.g. for performance diagnostics based on lactate measurement) Refer to “test mode” for safety information and adjustment. Parameter Default value Starting speed 8.0 km/h Increment 2.0 km/h Acceleration level Step length 3:00 min Break time 0:30 min Each parameter is adjustable.
18.4 Bruce protocol Description Illustration e.g. for ECG stress test Refer to “test mode” for safety information and adjustment. Step Duration (min) Speed (km/h) Elevation (%) 3:00 18.5 Naughton protocol Description Illustration e.g. for ECG stress test Regard chapter “test mode” for safety information and adjustment. Step Duration (min) Speed (km/h)
18.7 Cooper protocol Description Illustration e.g. for ECG stress test Refer to “test mode” for safety information and adjustment. Start at 5.3 km/h and 0% elevation ❚ After 1 minute elevation increases to 2 % ❚ After another minute, the elevation is increased by 1% every minute ❚...
18.10 Ramp profile Description Illustration (not available for every model) Refer to “test mode” for safety information and adjustment. Ramp profile with 2 parameters: Target speed standard: 10.0 km/h; adjustable from 0 to maximum ❚ speed of the treadmill. Time for reaching target speed in seconds: standard: 10 seconds; ❚...
18.12 Self-defined tests Tests 21 – 28 are freely definable with up to 40 program steps. Follow the instructions below to program an individual test. The “heart rate” display will show the current program step. Use “up” and “down” to scroll through the program steps. Basic functions Buttons / displays Further information...
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Basic functions Buttons / displays Further information Select acceleration for step 1 The acceleration level is displayed with “+” or “-“. in the “index” display. Confirm with “enter”. Proceed the same way for further steps. Make sure all steps after the last one have a speed of “0 km/h”.
19 Annex III (Accessories) 19.1 Arm support, adjustable [cos12013] Title Description Short description The h/p/cosmos arm supports are a simple solution for unweighting of the patient. Height and width adjustability offers a wide field of application. Illustration Application Adjust the arm support by pulling the locking element and turning the segments.
19.2 Arm support, optional stop button [cos10107, cos10108] Title Description Short description Additional emergency stop, integrated into arm support Illustration Application Operation Result Release Restart Running belt stops with predefined deceleration Movement of elevation system stops UserTerminal Push button Release button displays “pull stop”...
19.3 Crossbar front rail [cos102426] Title Description Short description Crossbar for additional balance control Illustration Application Patient may hold crossbar front rail for balance control Holding handrails during use affects exercise results. Additional safety information Technical data Length: 700 mm Diameter: 40 mm Weight:...
19.4 Elevation 0% to +25% [cos102927] Title Description Short description Extends elevation to 25% (22.5°) Illustration Application Additional safety information Technical data Max. elevation: 22.5° Additional accessories Installation No retro-fitting Further information page 71 cos105000-2016-00 en...
19.6 Handrail, long 1358mm [cos102918] Title Description Short description Long handrail for additional safety Illustration Application Patient has to hold both handrails for stability when entering the treadmill. Patient may hold handrails for balance control. Holding handrails during use affects exercise results. Additional safety information Technical data Length:...
19.7 Handrail, pediatric [cos102400] Title Description Short description Additional handrail for small patients Illustration Application Patient may hold handrails for balance control. Holding handrails during use affects exercise results. Additional safety information Technical data Length: 910 mm Width: 855 mm Height: 543 mm Max.
19.8 Heart rate measurement POLAR non-coded [cos102818] Title Description Short description Heart rate measurement, non-coded Illustration Application Apply chest belt as shown: Additional safety information WARNING! Heart rate monitoring systems may be inaccurate. ❚ Incorrect or over exercising may result in serious injury or death. ❚...
19.9 Heart rate measurement POLAR W.I.N.D. coded [cos100106] Title Description Short description Heart rate measurement coded Illustration Application Apply chest belt as shown: Additional safety information WARNING! Heart rate monitoring systems may be inaccurate. ❚ Incorrect or over exercising may result in serious injury or death. ❚...
19.10 PC-software para control [cos10071-v4.1.0] Title Description Short description The h/p/cosmos para control is designed for remote control of medical devices. But it does not perform medical diagnosis or evaluation. The read out data shall not be the basis for diagnosis or evaluation. For remote control of all h/p/cosmos running machine and ladder-ergometers with MCU2, MCU3, MCU4 and MCU5.
19.11 robowalk expander [cos30022, cos30023] Title Description Short description The h/p/cosmos robowalk expander supports gait training. Expander ropes, attached to the limbs, support or load the patient. Illustration Application See separate instructions for use. Additional safety information See separate instructions for use. Technical data Height: approx.
19.12 Safety arch for treadmill families 150/50 LC and 150/50 [cos10079] Title Description Short description The h/p/cosmos safety arch one option to secure the patient from falling. Furthermore, the safety arch stops the treadmill in case of falling. Illustration Application See “fall prevention”...
19.13 Wheelchair ramp [cos102931] Title Description Short description Wheelchair ramp supports entering the device with wheelchair patients. Illustration Application Push patient with wheelchair onto treadmill. Connect patient to fall prevention device. Support patient so they can stand upright. Remove wheelchair. Start application.
20 Contact For any service or sales enquiries, please have the model type and serial number of your device ready. For service support, we recommend using Skype with webcam. Sales & Service carefusion GmbH Leibnizstrasse 7 DE 97204 Hoechberg-Wuerzburg Germany...