AHTO Product Description and Intended Use Rev E

Irrigation Pump

Endoscopy

AHTO Irrigation Pump Irrigation Pump

Operation and Maintenance Manual REF 250-070-601

0197

Stryker European Representative Regulatory Manager ZAC Satolas Green Pusignan Av. de Satolas Green 69881 MEYZIEU Cedex, France

5900 Optical Court San Jose, CA 95138 USA 1-408-754-2000 1-800-624-4422

Table of Contents Warnings and Cautions ...4 Product Description and Intended Use ...6 Setting Up the Unit...8 Operating the Unit ...9 Troubleshooting ...13 Technical Specifications...14 Electromagnetic Compatibility...15 Warranty Statement ...19 Service and Claims...19 Other Service ...20

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Warnings and Cautions Please read this manual and follow its instructions carefully. The words warning, caution, and note carry special meanings and should be carefully reviewed: WARNING The personal safety of the patient or physician may be involved. Disregarding this information could result in injury to the patient or physician. Caution

Special service procedures or precautions must be followed to avoid damaging the instrument.

Note Special information to make maintenance easier or important information more clear. An exclamation mark within a triangle is intended to alert the user to the presence of important operating and maintenance instructions in the literature accompanying the product. A lightning bolt within a triangle is intended to warn of the presence of hazardous voltage. Refer all service to authorized personnel. To avoid potential serious injury to the user and the patient and/or damage to this device, the user must: 1. Read this operating manual thoroughly and be familiar with its contents prior to using this equipment. 2. Carefully unpack the unit and check if any damage occurred during shipment. If damage is detected, please refer to the Service and Claims section in this manual. 3. Be a qualified physician, having complete knowledge of the use of this equipment. 4. Test this equipment prior to a surgical procedure. 5. Attempt no internal repairs or adjustments not specifically detailed in this operating manual. 6. Never disassemble, open, puncture, or shred the batteries under any conditions. 7. Never short circuit the batteries. 8. Never use in the presence of flammable anesthetics, other flammable gases, near flammable fluids or flammable objects. 9. Never use in oxygen enriched atmospheres, nitrous oxide atmospheres, or in the presence of other oxidizing agents.

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10. Remove the batteries if the device is not likely to be used for a long period of time. The warranty is void if any of these warnings are disregarded. Stryker Endoscopy accepts full responsibility for the effects on safety, reliability, and performance of the equipment only if: • Readjustments, modifications, and/or repairs are carried out exclusively by Stryker Endoscopy. • The electrical installation of the relevant operating room complies with the applicable IEC, CEC, and NEC requirements. WARNING Federal law (United States of America) restricts this device to

use by, or on order of a physician. Stryker Endoscopy reserves the right to make improvements in the product(s) described herein. Product(s), therefore, may not agree in detail to the published design or specifications. All specifications are subject to change without notice. Please contact the local Stryker Endoscopy Distributor listed in the Other Service section or phone your local Stryker Endoscopy sales representative or agent for information on changes and new products.

Symbol Definitions C

US

Denotes compliance to CSA C22.2 No 601.1-M90 and UL 60601-1. Recycle Type BF applied part

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Product Description and Intended Use The AHTO Irrigation Pump is a motorized irrigator device used to facilitate irrigation in surgical procedures. The pump system delivers three flow rates to surgical sites: Low (2 L/minute), Medium (3 L/minute), and High (4 L/minute). The unit may be powered by either AC power or by a built-in, rechargeable battery pack. The battery pack lasts for approximately 30 standard surgical cases (~ 2 weeks) at the high flow rate, and more cases at the medium and low flow rates. Figure 1 below lists the parts of the AHTO Pump as described in this manual. Console Front

Console Rear 1

6 7

2 3

10

8

4 9 5

Figure 1: The AHTO Irrigation Pump and its components

1. Console

6. Clamp

2. Control Membrane

7. AC Inlet

3. Coupler

8. AC Power Cord

4. Latch Detents

9. Power Cord Holder

5. Console Contacts

10. Clamp Screw

Note The AHTO Irrigation Pump is intended for use only with the Stryker AHTO Tube Set (P/N 250-070-600 and 250-070-620). Note The duration of a standard surgical case is 1.5 hours, with the motor running intermittently in short (1-3 sec.) bursts, consuming 1L of fluid.

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Battery

Tube Set 11

12 13

14

15

16

17 18

19

Figure 2: The AHTO Tube Set and the AHTO Irrigation Pump battery assembly

11. Cassette

16. Spike

12. Cassette Contacts

17. Battery Door

13. Handpiece

18. Screw

14. Suction Adapter

19. Battery

15. Tubing Control Membrane

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20

21

22

Figure 3: The AHTO Irrigation Pump control membrane

20. Battery Check Button (p. 11)

23. Suction Adapter

21. Battery Level Indicator (p. 11)

24. Flow Rate Display (p. 10)

22. Flow Rate Selection Buttons

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Setting Up the Unit

1

2 1. Screw in the clamp screw.

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3

2. Remove the battery cover with a #1 Phillips screwdriver. 3. Remove the battery pack from the console. Note If replacing the battery pack, disconnect the battery wire connectors, and properly discard the old battery (p. 12). 4. Connect battery wire connectors to battery pack. Note Do not use force when aligning the latch to the tab.

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5

7

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5. Insert the battery pack into the console to the right of the battery wires. 6. Insert the battery cover and screw into place. 7. Position the console below the irrigation bag, 12” above the highest surface of the patient. Tighten the clamp screw to mount the console to the IV pole. 8. Connect the power cord to the console. Plug the cord into an electrical outlet to charge the batteries Caution

Ensure the unit is free from all liquid before plugging in.

Note The battery pack takes 1.5 hours to charge. “FC” will appear on the flow rate display when fully charged.

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Note A charged AHTO Irrigation Pump will run on batteries for approximately 30 cases at the high flow rate. When the batteries are low, the bottom light on the battery level display will flash red, indicating enough battery life for one typical case and the need for recharging. Note To run the console using the battery pack, wind and store the cord in the cord holder.

Operating the Unit 1. Remove the tube set (P/N 250-070-600 or 250-070-620) from its pouch. 2. Spike the Irrigation Bag. Ensure that the distance between the console and the bag gives the tubing some slack.

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3. Connect suction adapter to wall suction. 4. Insert cassette. Ensure both tabs on the cassette are properly latched onto the pump. (The latches will sound 2 “clicks”).

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Note The system powers on and off automatically when the cassette is inserted and removed from the pump. 5. Select the desired flow rate. L = 2L/min. M = 3L/min. H = 4L/min.

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6. Attach the appropriate irrigation tip. WARNING Ensure the irrigation tip is free from damage or rough surfaces prior to use.

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Note Follow proper hospital protocols for use of electrosurgical equipment and probes. 7. To prime the system, ensure the handpiece is at least 18” below the Irrigation Bag. (24” and greater is recommended).

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8. Press the blue button for irrigation. Press the red button to aspirate. Irrigate

Aspirate

WARNING The system is intended for short bursts of irrigation, with a maximum irrigation time of 15 seconds every 2 minutes. High temperatures may result if the system is activated for longer periods.

Flow Rate Display The Flow rate display shows the current flow rate of the Irrigation Pump. When the system is priming, the display will flash. When the cassette is inserted and the irrigation button is not depressed, the display will remain solid.

Table 1: Flow Rate Display Display C

Meaning Cassette not present; System is charging

FC

Cassette not present; Unit is fully charged

E1

Rotation of motor impeded

E2

Batteries are empty

E3

Cassette not present; Batteries not plugged in or improperly connected Power cord is plugged into unit

L

2 L / min.

M

3 L / min.

H

4 L / min.

Re-Spiking an Irrigation Bag When re-spiking a bag, perform the following steps: 1. Remove the AHTO tube set cassette from the AHTO Irrigation Pump. 2. Re-spike the bag. 3. Reinsert the cassette into the pump.

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Battery Level Display The Battery Level Display shows the current level of charge left in the battery pack.

Table 2: Battery Level Display Display

Meaning

2 bars

Current battery level

1 top bar

Batteries fully charged

1 solid bar with scrolling bars underneath

Unit is charging; Current level shown by solid bar

1 bottom bar, flashing

When bar appears, there is enough charge remaining for one typical case only

Battery Check Button: When the system is unplugged and no cassette is present, the battery level may be checked by depressing the Battery Check button.

Recharging the Battery Pack When a red bar is illuminated on the Battery Level Display, the battery pack will need recharging. To recharge the battery, plug the unit in to an AC outlet. The Battery Level Display will show the current charge level during charging and will shine steady when charging is complete (an “FC” will appear in the flow rate display and no cassette is present). Complete charging takes approximately 1.5 hours. Note A fully charged battery pack will power approximately 30 cases at the high flow rate. When the unit or the AC power cord is not in use, wrap the power cord using the cord tie in the back of the unit. Note If the battery pack does not provide at least 15 standard cases (at the high flow rate), the battery pack needs replacement. Note If the unit is not being used for a period of time exceeding 2 months, disconnect the battery pack.

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Cleaning and Maintenance WARNING Caution

Unplug the unit from the electrical outlet before cleaning.

Do not sterilize the unit.

1. Wipe the unit with a soft cloth dampened in a mild cleaning solution. 2. Clean the unit with disinfectant if needed.

Fuse Replacement In the event that fuses need replacement, perform the following steps: 1. Locate the fuse holder next to the AC inlet. 2. Squeeze the tabs to remove the fuse holder cover. 3. Remove the old fuses and replace with new 1A 250V fuses. 4. Reattach the fuse holder cover to complete installation.

Battery Pack Replacement The battery pack should be replaced every 1.5 - 2 years, and must be replaced only with the Stryker Battery Pack (P/N 250-070-602). WARNING Never replace the battery pack in the vicinity of the patient.

Installing a New Battery Pack Follow steps 1-6 in the “Setting Up the Unit” section (p. 8).

Battery Disposal Follow the proper disposal procedures for nickel-metal hydride cells. As a minimum standard, observe the following : • Contact the local environmental agency for information on recycling nickel-metal hydride batteries. • Ensure the batteries are fully discharged prior to disposal. • Do not incinerate. • Observe all national, state, and local rules and regulations for disposal of rechargable batteries.

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Software Revisions Checking the Software Revision Level 1. Depress the Battery Check,

, and

buttons simultaneously.

2. The current software revision will scroll in the Flowrate Display.

Troubleshooting Note If the following solutions do not resolve the noted problem, contact Stryker Endoscopy for repair (see the “Service and Claims” section, p. 19). Problem

Solution

System does not power on when cassette is inserted

Ensure cassette is fully inserted into the console, with both latches clicking into position. Ensure the AC power cord is properly connected to a hospital grade power outlet, and the inlet on the rear console panel. The batteries may need to be charged. Ensure the proper operation of all fuses. See the ‘Fuse Replacement’ section of this manual for further instructions. Replace tube set as it may be defective.

Motor does not turn on when irrigation button is pressed

Ensure cassette is fully inserted into the console, with both latches clicking into position. Ensure the cassette contacts and console contacts are clean and free of debris and buildup. Replace tube set as it may be defective.

Low flow rates or system does not prime

Ensure the Irrigation Bag is not kinked at the exit nozzle. Ensure the handpiece is at least 18” below the saline bag. Toggle through the arrows to a higher flow rate setting.

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Technical Specifications Electrical Primary Fuses Battery

100-240V~ 50/60 Hz, 1A 1A 250V 14 AA Ni-MH connected in series, 19.6V 1800 mAhrs.

Dimensions Height Width Depth Weight

7.5” (19.1cm) 6.0” (15.2 cm) 3.7” (9.4 cm) 4.4lbs. (2.0 kg)

Operating Conditions

10° to 40° C 30% to 75% relative humidity

Transportation and Storage

-20° to 60° C 10 % to 75% relative humidity 700 hPa to 1060 hPa

Classifications and Approvals • Type BF Applied Part • IPX2 Degree of protection against water ingress • Continuous operation with intermittent activation • Class 1 and Internally Powered • Equipment

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• Complies with Medical Safety Standards • IEC 60601-1: 1998 + A1: 1991 + • A2: 1995 • CSA C22-2 No. 601.1-M90 • UL60601-1: 2003 • AS 3200.1.0: 1998 • IEC 60601-2-18: 1996 + A1: 2000

Electromagnetic Compatibility Like other electrical medical equipment, the AHTO Irrigation Pump requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC), the AHTO Irrigation Pump must be installed and operated according to the EMC information provided in this manual. The AHTO Irrigation Pump has been designed and tested to comply with IEC 60601-1-2:2001 requirements for EMC with other devices. WARNING Do not use cables or accessories other than those provided with the AHTO Irrigation Pump, as this may result in increased electromagnetic emissions or decreased immunity to such emissions. WARNING If the AHTO Irrigation Pump is used adjacent to or stacked with other equipment, observe and verify normal operation of the AHTO Irrigation Pump in the configuration in which it will be used prior to using it in a surgical procedure. Consult the tables below for guidance in placing the AHTO Irrigation Pump. Caution

Portable and mobile RF communications equipment may affect the normal function of the AHTO Irrigation Pump.

Guidance and Manufacturer's Declaration: Electromagnetic Emissions AHTO Irrigation Pump is intended for use in the electromagnetic environment specified below. The customer or the user of AHTO Irrigation Pump should ensure that it is used in such an environment. Emissions test

Compliance

Electromagnetic Environment - guidance

RF emissions CISPR 11

Group 1

AHTO Irrigation Pump 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 B

Harmonic emissions IEC61000-3-2

Class A

Voltage Fluctuations/ flicker emissions IEC61000-3-3

Complies

AHTO Irrigation Pump 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.

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Guidance and Manufacturer's Declaration: Electromagnetic Immunity AHTO Irrigation Pump is intended for use in the electromagnetic environment specified below. The customer or the user of AHTO Irrigation Pump should ensure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment: Guidance

Electrostatic Discharge (ESD) IEC61000-4-2

±6kV contact ±8kV air

±2,4,6kV contact ±2,4,8kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/ burst IEC61000-4-4

±2kV for power supply lines ±1kV for input/ output lines

±2kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC61000-4-5

±1kV differential mode ±2kV common mode

±0.5, 1kV differential mode ±0.5, 1, 2kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11

<5% Ut (>95% dip in Ut) for 0.5 cycle 40% Ut (60% dip in Ut) for 5 cycles 70% Ut (30% dip in Ut) for 25 cycles <5% Ut (>95% dip in Ut) for 5 sec.

<5% Ut (>95% dip in Ut) for 0.5 cycle 40% Ut (60% dip in Ut) for 5 cycles 70% Ut (30% dip in Ut) for 25 cycles <5% Ut (>95% dip in Ut) for 5 sec.

Mains power quality should be that of a typical commercial or hospital environment. If the user of AHTO Irrigation Pump requires continued operation during power mains interruptions, it is recommended that AHTO Irrigation Pump be powered from an uninterruptible power supply or a battery.

Power frequency (50/ 60Hz) magnetic field IEC 61000-4-8

3 A/m

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N/A

Power-frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Guidance and Manufacturer's Declaration: Electromagnetic Immunity AHTO Irrigation Pump is intended for use in the electromagnetic environment specified below. The customer or the user of AHTO Irrigation Pump should ensure that it is used in such an environment. NOTE: Ut is the a.c. mains voltage prior to application of the test level.

Immunity Test

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 AHTO Irrigation Pump system, including its cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended Separation Distance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3V

3 V/m 80MHz to 2.5 GHz

3 V/m

d = 1.17 P

d = 1.17 P 80 MHz to 800 MHz d = 2.33 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 meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey (a), should be less than the compliance level in each frequency range(b). 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.

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(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 AHTO Irrigation Pump system is used exceeds the applicable RF compliance level above, the AHTO Irrigation Pump system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the AHTO Irrigation Pump unit. (b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the AHTO Irrigation Pump

The AHTO Irrigation Pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the AHTO Irrigation Pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AHTO Irrigation Pump as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power (W) of transmitter

Separation distance (m) according to frequency of transmitter 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.17 P

d = 1.17 P

d = 2.33 P

0.01

0.12

0.12

0.23

0.1

0.37

0.37

0.74

1

1.17

1.17

2.33

10

3.70

3.70

7.37

100

11.70

11.70

23.30

For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (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.

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Warranty Statement This Stryker Endoscopy product is warranted to the original purchaser for a period of one year from the date of purchase to be free from defects in material and workmanship. This warranty extends to all purchases and is limited to the repair or replacement of the product without charge when returned to: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA Stryker Endoscopy cannot accept responsibility for returns or replacements which have not been authorized. This warranty does not cover damages caused by misuse (i.e. neglect, dropping, or denting) or by failure to follow the procedures outlined in this manual or demonstrated by Stryker Endoscopy representatives. Unauthorized repair or modifications to the AHTO Irrigation Pump may void the warranty and invalidate the user’s authority to use the product. There are no other expressed warranties.

Service and Claims Caution

Do not attempt to service this product yourself. If service is needed either during or after the warranty period:

1. Contact Stryker Endoscopy at 1-800-624-4422, or phone your local Stryker Endoscopy sales representative. 2. Clean all parts that will be returned for service. Follow the instructions provided in this manual. 3. Package all the components carefully in the original shipping container if possible. 4. Ship the unit, pre-paid and insured to: Stryker Endoscopy Customer Service Attention: Repair Department 5900 Optical Court San Jose, CA 95138 Note The product described in this manual is continually being reviewed, and improvements may be made without notice. © Stryker and Stryker Endoscopy are registered trademarks of Stryker Corporation.

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