stryker System 9 Sterile Battery Charger Instructions

stryker System 9 Sterile Battery Charger

Important Information

Using this Manual
This manual is the most comprehensive source of information for the safe, effective, and compliant use and/or maintenance of your product. This product is intended for use by trained and experienced healthcare professionals only. Read and understand this manual before using the product or any component compatible with the product. Contact Stryker for training as needed. This manual is a permanent part of the product. Keep this manual for future reference.
The following signal words may be used throughout this manual:

WARNING – Highlights a safety-related issue. Always comply with this information to prevent patient and/or healthcare staff injury.
CAUTION – Highlights a product reliability issue. Always comply with this information to prevent product damage.
NOTE – Supplements and/or clarifies procedural information.

Contact Information

• Stryker Representative
• 1-269-323-7700, 1-800-253-3210
• inst.stryker.cs@stryker.com
• www.stryker.com

NOTE – The user and/or patient should report any serious product-related incident to both the manufacturer and the Competent Authority of the European Member State where the user and/or patient is established.

Indications For Use

The Stryker System 9 Sterile Battery Charger is intended to inductively charge appropriate Stryker Battery Packs. The batteries can be charged while in sterile blue wrap or in their native form by placing them directly onto the charger.

Contraindications

None known.

For Use With

WARNING

• Use only Stryker-approved equipment, unless otherwise specified.
• Use only Stryker-approved electronic components and accessories. Failure to comply may result in degraded performance, increased electromagnetic emissions, or decreased electromagnetic immunity of the system.

NOTE – Contact Stryker for a complete list of accessories.
To obtain a safe combination, the charger must be used with System 9 batteries and a Stryker-approved power cord

NOTE – For power cord options that meet country-specific requirements and are acceptable for use with the charger, see Specifications.

Safety Directives

WARNING

• Healthcare professionals should be thoroughly familiar with the instructions for use and the operation of this product prior to use.
• Always inspect the product and all system components for damage upon initial receipt and before each use. Do not use the product if damage is apparent.
• Do not use this product in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen, or nitrous oxide.
• Take special precautions regarding electromagnetic compatibility (EMC) when using this product. Install and/or put this product into service per the EMC information contained in this manual. Portable and mobile radio frequency (RF) equipment can affect the function of this product.
• Always operate the product within the specified environmental condition values; see Specifications.
• The System 9 Sterile Battery Charger is limited to professional use within a professional healthcare environment, excluding near high frequency (HF) surgical equipment and accessories; see Electromagnetic Compatibility.
• Do not modify any equipment.

CAUTION – Do not use this product to charge anything except compatible Stryker System 9 batteries.

Definitions
NOTE – Additional product and/or labeling symbols are defined in the Symbol Definition Chart supplied with the product. See also Disposal/Recycle.

Additional Definitions

Manufacturer (BS EN ISO 15223-1 5.1.1)

| Authorized representative in the European Community (BS EN ISO 15223-1 5.1.2)
| ****

Date of manufacture (BS EN ISO 15223-1 5.1.3)

| Catalog number (BS EN ISO 15223-1 5.1.6)
| Serial number (BS EN ISO 15223-1 5.1.7)
| Consult instructions for use (BS EN ISO 15223-1 5.4.3)
| ****

Caution (BS EN ISO 15223-1 5.4.4)

****| Medical device (BS EN ISO 15223-1 5.7.7)

| Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. (CFR 801.109(b)[1])
| Non-ionizing electromagnetic radiation (IEC 60417 5140)
| ****

Importer (BS EN ISO 15223-1 5.1.8)

Product Overview

Charger
The System 9 Sterile Battery Charger (Figure 1) has 6 bays to charge System 9 Battery Packs (large or small) through inductive (wireless) charging. The battery packs can be charged before sterilization while (1) unwrapped or after sterilization while (2) wrapped in sterilization wrap. The charger has an illuminated display panel that shows charger, bay, and battery status, including cycle counts.

System 9 Sterile Batteries; see For Use With. Each charger bay has a corresponding battery status indicator (H) on the display panel, numbered 1 through 6.
B|

Ethernet Port – Used to export device usage data from the charger to Stryker via Stryker’s Cloud; see Figure 2.

C| MAC ID Label – Media Access Control Identifier (MAC Address).
D| Power Cord Receptacle – Allows connection of the power cord.
E| Power Cord – Connects the charger to a facility power receptacle.
F

| Cycle Button – Press the cycle button to:

▪       Choose the power mode during initial setup; see To Connect the Charger.

▪       Wake up the charger from standby (asleep) mode; see Power Modes.

▪       Toggle through the charger bays to see the cycle count for each battery; see To Check Battery Cycle Count.

G| Cycle Count – The number of charge cycles on the selected battery.
H|

Battery Status Indicator – Shows the status of the battery; see State of Charge.

I|

Bay Status Indicator – Bar that illuminates below the selected battery status indicator(s).

J| Power Mode Indicator – Illuminates when the charger is connected to a facility power receptacle. The color indicates the charger power mode; see Power Modes.

Power Modes

The color of the power mode indicator tells you whether the charger is operating in eco mode or standard mode. To set or change the power mode, see To Set the Power Mode.

Blue

| Eco (economy) mode –

Power saving mode that allows the charger to go on standby (asleep) when:

▪       all batteries are charged,

▪       no errors are detected, and

▪       there is no activity for 180 minutes.

The power mode indicator flashes blue when the charger is on standby; see To Set the Power Mode.

Green

| Standard mode – Regular operating mode. The charger will never go on standby (asleep) while in standard mode.

State of Charge

The battery status indicator uses 3 light bars to display the state of charge for each battery. A flashing bar indicates the rising state of charge.

Medium Charge – 2 solid green bars, 1 flashing green bar

|

Low Charge – 1 solid green bar, 1 flashing green bar

|

No Charge – 1 flashing green bar

Error State
An amber light(s) on the display panel indicates an error state for the battery or charger.

Getting Started

To Connect the Charger
WARNING

• To avoid the risk of electric shock, always connect this product to a hospital-grade, facility power receptacle with protective earth (ground).
• Always use the appropriate charger to charge batteries.
• Do not operate the charger using a voltage inconsistent with the rating on the back of the unit.
• Do not operate the charger with a damaged power cord or plug.
• Do not modify the power cord.
• Always position the product so that the power cord can be easily disconnected.
• Do not place the charger within the sterile field.
• Do not touch the battery charger and the patient simultaneously. Failure to comply may cause electrical shock.
• Metal objects between battery pack and charger may get hot. To avoid the risk of burns, do not put any metal device on the charger.

CAUTION

• Do not put any near field communication (NFC) enabled device on the charger.
• Always position the power cord where it will not be stepped on, tripped over, or otherwise subjected to damage or stress.

1. Use the power cord to connect the battery charger to a hospital-grade, facility power receptacle (Figure 2).

2. OPTIONAL: Use an Ethernet cable (not supplied) at least 3 meters in length to connect the Ethernet port to a facility Ethernet receptacle.
   NOTE

   • Confirm with a facility IT representative that the Ethernet receptacle has access to the Internet.
   • See the network requirements in the Specifications section.
   • For more information, contact your Stryker sales representative.

To Set the Power Mode

Upon initial connection to facility power, the power mode indicator illuminates solid green to indicate that the charger is operating in standard mode.

1. Choose the ongoing power mode for the charger. See Power Modes for mode descriptions.
   • To operate the charger in standard mode, no further action is needed. The charger is ready to use.
   • To operate the charger in eco (economy) mode, hold the cycle button for 7 seconds. The power mode indicator will turn solid blue.

NOTE – Change the power mode any time by holding the cycle button for 7 seconds.

Using Your Product

To Charge a Battery
CAUTION – When battery packs require postsurgical sterilization, always allow the battery packs to cool for one hour before charging. Excess heat buildup from sterilization and charging will damage the battery packs.

NOTE

• For maximum capacity, charge the battery between each use.
• A typical charging sequence takes between 5 and 30 minutes. A fully expended, large battery may take up to 150 minutes to charge. Ensure the battery is at room temperature before charging.

1. If operating in eco (economy) mode and the charger is on standby (the power mode indicator is flashing blue), first press the cycle button to wake up the charger.

2. Load the clean, dry battery(s) onto the charger in any one of the following configurations:
   Before sterilization (Figure 3):

   • individually, unwrapped After sterilization (Figure 4):

   • individually, wrapped in sterilization wrap
     NOTE – For wrapped battery packs, ensure the sterilization wrap is:

   • approved by an applicable regulatory body

   • labeled for use with the validated sterilization parameters in the System 9 Processing Instructions manual supplied with the handpiece

   • wrapped flat and tight across the bottom of the battery
     WARNING – If a metal-backed sterilization indicator is included in the sterilization wrap, make sure the indicator is not positioned near the bottom (charger side) of the battery. Failure to comply will result in a metal detection error, the battery will not charge, and the metal object may get hot; see Troubleshooting.

3. Make sure the flat bottom of the battery pack is completely situated within the charger bay and fully in contact with the charger surface (Figure 5).

4. Upon contact with the battery, the battery status indicator for the occupied charger bay flashes green while the battery communicates with the charger.
   NOTE – If the charger detects a misaligned battery or a metal object between the battery pack and the charger bay, the battery status indicator for that bay displays 3 solid amber bars, and the bay status indicator (bar) flashes amber; see Troubleshooting.

5. After a few seconds, the battery status indicator displays the state of charge; see State of Charge.

6. Once the charging sequence begins, the target state of charge bar on the battery status indicator flashes continuously to indicate that charging is in process (Figure 6). 7. When the battery is fully charged, the battery status indicator displays 3 solid green bars (Figure 7).

To Check Battery Cycle Count

1. Press the cycle button to select a battery. The bay status indicator for that battery illuminates solid blue (Figure 8).
2. The number of charge cycles for the selected battery displays in blue above the cycle button.

To Disconnect the Battery Charger
CAUTION

• To reduce the risk of damage to the power cord, always pull the power cord plug, not the power cord, when disconnecting the battery charger.
• Some power cords have a locking mechanism to prevent accidental disconnection. To remove a power cord with a locking mechanism, slide back the red locking tab.

1. Disconnect the battery charger from the facility power receptacle.
2. Disconnect the battery charger from the Ethernet receptacle.

After Use

Cleaning
WARNING – Before cleaning, always disconnect the power cord from the facility power receptacle and the battery charger to reduce the risk of electric shock.

CAUTION

• Do not immerse the product in liquid.
• Do not use solvents, lubricants, or other chemicals, including glutaraldehyde or similar chemical cleaners, unless otherwise specified.
• Do not allow liquid or moisture to enter any electrical connection or the cooling vents on the back of the charger.
• Do not sterilize the product.

1. Disconnect the power cord from the facility power receptacle and the battery charger.
2. Disconnect the Ethernet cable, if used, from the Ethernet port.
3. Wipe all external surfaces of the battery charger and power cord with a soft, non-linting cloth moistened with a prepared cleaning solution or non-abrasive hospital disinfectant and water.
4. Dry the equipment with a clean, non-linting cloth or medical-grade compressed air.
5. Inspect the battery charger and power cord for damage; see Inspection.

Inspection

WARNING

• Only individuals trained and experienced in the maintenance of reusable medical devices should inspect this equipment.
• Before inspection, always disconnect the power cord from the battery charger to reduce the risk of electric shock.
• Do not use any equipment if damage is apparent or the inspection criteria are not met.

NOTE

• If the equipment fails to meet the inspection criteria, contact Stryker for service.
• The useful life of this equipment is dependent upon many factors including, but not limited to, the method and duration of each use, and the handling of the equipment between uses.
• Routine inspection is the best method for determining the serviceable life span of the equipment.

signs of wear
No loose or missing components
No cuts in the power cord
No cracks in the housing

References

Storage and Handling
CAUTION

• Always store and transport the product within the specified environmental limitations.
• Always save the original packaging container for reuse. Failure to comply may result in damage during transport to the Stryker customer service center.

Disposal/Recycle

WARNING – Always follow the current local recommendations and/or regulations governing environmental protection and the risks associated with recycling or disposing of the product at the end of its useful life.

| In accordance with European Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE) as amended product should be collected separately for recycling. Do not dispose of as unsorted municipal waste. Contact local distributor for disposal information. Ensure infected equipment is decontaminated prior to recycling.
| To comply with China RoHS Standard SJ/T 11364, this device has been marked with the environmentally-friendly use period (EFUP) number, measured in years. The device contains at least one of the listed hazardous substances above threshold.

China RoHS Disclosure Report REF 9110-120-000

__

__

Part Name

| Hazardous Substances
---|---
Lead (Pb)| Mercury (Hg)| Cadmium (Cd)| Hexavalent Chromium (Cr (VI))| Polybrominated biphenyls (PBB)| Polybrominated diphenyl ethers (PBDE)
Electronic circuit boards and charger power supply| __

X

| __

O

| __

O

| __

O

| __

O

| __

O

This table is prepared in accordance with the provisions of SJ/T11364.

O: Indicates that said hazardous substance contained in all of the homogenous materials for this part is below the limit requirement of GB/T26572.

X: Indicates that said hazardous substance contained in at least one of the homogenous materials used for this part is above the limit requirement of GB/T26572.

Troubleshooting

of the battery charger and at the facility power receptacle; see To Connect the Charger.

Have qualified personnel confirm that the facility power receptacle is working properly.

If the charger remains unresponsive, contact Stryker for service.

All 6 bay status indicators flash amber to indicate a charger error.

| Reset the cord connections on the back of the battery charger and at the facility power receptacle; see To Connect the Charger.

If the error persists, contact Stryker for service.

Battery error: All 3 bars of the battery status indicator illuminate solid amber while battery is in contact with charger.| Remove the battery, wait 5 seconds, then reseat the battery in the charger bay. The bottom of the battery pack must be in full contact with the surface of the charger; see To Charge a Battery.

Try a different battery.

Try a different charger bay(s).

If the battery pack is enclosed in sterilization wrap, ensure the battery pack is properly wrapped (see To Charge a Battery) , and the bottom of the battery pack is in full contact with the surface of the charger.

If the error persists, contact Stryker for service.

Misaligned battery: Battery is not seated correctly on the charger; or

Metal object detected: All 3 bars of the battery status indicator illuminate solid amber, and the bay status indicator flashes amber.

or

If the alignment of the battery and removal of any metal objects have been verified, then condensation may have accumulated inside the battery during processing.

| Remove the battery, wait 5 seconds, then reseat the battery in the charger bay. The bottom of the battery pack must be in full contact with the surface of the charger; see To Charge a Battery.

Remove the metal object.

NOTE – The metal object may be located inside the sterilization wrap, between the battery and charger.

Try a different charger bay(s).

Process the battery per the Processing Instructions supplied with the handpiece. After the processing is complete, allow the battery to cool for a minimum of one hour before charging.

If the error persists, contact Stryker for service.

Bay error: The bay status indicator illuminates solid amber.| Remove the battery from the charger bay. The bay is disabled.

The remaining charger bays are still functional. Insert the battery into a different charger bay.

Reset the cord connections on the back of the battery charger and at the facility power receptacle; see To Connect the Charger.

If the error persists, contact Stryker for service.

The cycle count does not appear when you press the cycle button.| Contact Stryker for service.
The battery becomes unusually hot during use or while charging.| Return the battery to Stryker.
Sporadic electrical interference is experienced.| Turn off all electrical equipment not in use.

Relocate electrical equipment; increase spatial distance.

Install electrical equipment into different facility power receptacles.

Specifications

Charger

Model:| System 9 Sterile Battery Charger
REF:| 9110-120-000
Dimensions:| 105 mm [4.1 inch] height, 363 mm [14.3 inch] width, 314 mm [12.4 inch] length
Mass:| 4.4 kg [9.8 lb]
Material:| In accordance with the European REACH regulation and other environmental regulatory requirements, the charger contains the following substances that are identified as being above 0.1% w/w: Lead, CAS No. 7439- 92-1; Lead monoxide (lead oxide), CAS No. 1317-36-8; and Diboron trioxide, CAS No. 1303-86-2; and 1-Methyl- 2-Pyrrolidone (NMP), CAS No. 872-50-4. This declaration is made in good faith and is either based upon a technical evaluation, supplier data, and/or laboratory testing.
Mode of Operation:| Continuous Operation
Electrical Input:| 100-230 V, ~50-60 Hz, 3.35 A
Fuse:| T 5A H, 250 V
Ingress Protection:| IPX0
Equipment Type:| Class I
Ground Type:| Protective earth ground
Means of Isolation from Supply Mains:| Disconnect the power cord from the battery charger power cord receptacle.
Network Requirements|
Purpose of the Connection:| Device Usage Data
Required Network Characteristics:| Standard TCP/IP over Ethernet (IEEE 802.3 10/100 Mbs)
Required Network Configuration:| DHCP server, Mask and Gateway provided by site IT admin; Access to Stryker’s Cloud
Technical Specifications of the Connection:| Standard TCP/IP over Ethernet (IEEE 802.3 10/100 Mbs), utilized industry standard https (port 443) web services communication to Stryker’s Cloud.
Intended Information Flow:| Device Usage Data
Hazardous Situations Resulting from a Failure of the Network:| None known.

CAUTION – Subsequent changes to the IT network could introduce new risks and require additional analysis. The hospital IT admin should identify, analyze, evaluate, and control these risks. Changes to the IT network include: changes in network configuration, connection of additional items, disconnection of items, update of equipment, upgrade of equipment.

Wireless Power Transfer Frequency of Operation: RF Bandwidth: Modulation:

RF Field Strength:

| ****

129.7 kHz 125.5-133.9 kHz None

10.64 dBuV/m at 3m

Near-field Communication (NFC) Frequency of Operation:

RF Bandwidth: Modulation:

RF Field Strength:

| ****

13.56 MHz

13.553-13.567 MHz ASK

19.41 dBuV/m at 30m

Power Cord (general)
Ratings:|
Current:| 10 A
Voltage (nominal):| 250 VAC minimum
Frequency:| 50-60 Hz
Temperature:| 0 °C to 70 °C minimum
Flammability:| UL 94 V-2 minimum, IEC 60332-1
Conductor:|
Size:| 3 X 1.00 mm2 ≤ size < 3 X 1.50 mm2
Material:| Copper
Connector Type:| IEC 60320 C13
Plug Type:| The facility power (mains) plug shall have a ground/earthing pin.
Cord:|
Type:| SJT, H05VV-F, HVCTF, RVV or equivalent (unshielded)
Length:| 3.0 m, 2.5 m

NOTE – The 2.5 m cord is not for use in Canada or the US.

Dielectric Withstand:| 1500 VAC for 60 seconds between line and protective earth, and between neutral and protective earth
Certification:| All applicable in-country medical electrical requirements

Wireless Notifications

For wireless communication technology, these statements apply to the countries as indicated:

This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s licence-exempt RSS(s). Operation is subject to the following two conditions: (1) this device may not cause interference; (2) this device must accept any interference, including interference that may cause undesired operation of the device.

L’émetteur/récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR d’Innovation, Sciences et Développement économique Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes: (1) l’appareil ne doit pas produire de brouillage; (2) l’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en compromettre le fonctionnement.

To ensure compliance with FCC and ISED RF exposure requirements this device must be installed to provide a minimum of 20cm between the device and people.

Pour garantir la conformité aux exigences d’exposition RF de la FCC et d’ISED Canada, cet appareil doit être installé de manière à laisser un minimum de 20 cm entre l’appareil et les personnes.

United States of America| Complies with California Energy Commission (CEC) Battery Charger System Appliance Regulation Contains FCC ID: Q9R-9110120550

This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

To ensure compliance with FCC and ISED RF exposure requirements this device must be installed to provide a minimum of 20cm between the device and people.

Electromagnetic Compatibility
WARNING – Do not stack or place equipment adjacent to the product. If such a configuration is necessary, observe the configuration to ensure that electromagnetic interference does not degrade performance.

Guidance and manufacturer’s declaration – electromagnetic emissions

The System 9 Sterile Battery Charger (REF 9110-120-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the System 9 Sterile Battery Charger (REF 9110-120-000) should assure that it is used in such an environment.
Emissions test| Compliance| Electromagnetic environment – guidance
RF emissions CISPR 11| Group 1| The System 9 Sterile Battery Charger (REF 9110-120-000) 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| NOTE – The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radiofrequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

The System 9 Sterile Battery Charger (REF 9110-120-000) is suitable for use in all establishments other than domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

| Complies
Voltage fluctuations/flicker emissions

IEC 61000-3-3

| Complies
Guidance and manufacturer’s declaration – electromagnetic immunity

The System 9 Sterile Battery Charger (REF 9110-120-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the System 9 Sterile Battery Charger (REF 9110-120-000) should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
Electrostatic discharge (ESD)

IEC 61000-4-2

| ±2 kV, ±4 kV, ±6 kV, ±8 kV

contact

±2 kV, ±4 kV, ±8 kV, ±15

kV air

| ±2 kV, ±4 kV, ±6 kV, ±8 kV

contact

±2 kV, ±4 kV, ±8 kV, ±15

kV air

| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 20%.
Electrical fast transient/ burst

IEC 61000-4-4

| ±2 kV at 100 kHz repetition frequency for power supply lines

±1 kV at 100 kHz repetition frequency for input/output lines

| ±2 kV at 100 kHz repetition frequency for power supply lines

±1 kV at 100 kHz repetition frequency for input/output lines

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

IEC 61000-4-5

| ±0.5, ±1 kV line(s) to line(s)

±0.5, ±1, ±2 kV line(s) to earth

| ±0.5, ±1 kV line(s) to line(s)

±0.5, ±1, ±2 kV line(s) to earth

| 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

IEC 61000-4-11

| <5% U T (>95% dip in U T)

for 0.5 cycle

40% U T (60% dip in U T) for 5 cycles

0% U T (100% dip in U T ) for 0.5 cycle at 0°, 45°, 90°,

135°, 180°, 225°, 270°, and

315°

0% U T (>100% dip in U T ) for 1 cycle at 0°

70% U T (30% dip in U T) for 25 & 30 cycles at 0°

<5% U T (>95% dip in U T)

for 5 s

0% U T __ (100% dip in U T )

for 5 s

| <5% U T (>95% dip in U T)

for 0.5 cycle

40% U T (60% dip in U T) for 5 cycles

0% U T (100% dip in U T ) for 0.5 cycle at 0°, 45°, 90°,

135°, 180°, 225°, 270°, and

315°

0% U T (>100% dip in U T ) for 1 cycle at 0°

70% U T (30% dip in U T) for 25 & 30 cycles at 0°

<5% U T (>95% dip in U T)

for 5 s

0% U T __ (100% dip in U T )

for 5 s

| Mains power quality should be that of a typical commercial or hospital environment. If the user of the System 9 Sterile Battery Charger (REF 9110- 120-000) requires continued operation during power mains interruptions, it

is recommended that the System 9 Sterile Battery Charger (REF 9110-120- 000) be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8

| 3 A/m, 30 A/m| 3 A/m, 30 A/m| 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

The System 9 Sterile Battery Charger (REF 9110-120-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the System 9 Sterile Battery Charger (REF 9110-120-000) should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
Conducted RF IEC 61000-4-6| 3 Vrms 150 kHz to 80 MHz outside ISM bands 80% AM at 1 kHz

6 Vrms 150 kHz to 80 MHz in ISM bands 80% AM at 1 kHz

|

N/A

| Portable and mobile RF equipment should be used no closer to any part of the System 9 Non- Sterile Battery Charger (REF 9110-120-000), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Radiated RF

IEC 61000-4-3

| 3 V/m 80 MHz to 2.5 GHz 80% AM at 1 kHz| 3 V/m 80 MHz to 2.5 GHz 80% AM at 1 kHz| Recommended separation distance:

150 kHz to 80 MHz d =1.17√P

| 27 V/m 385 MHz Pulse modulation 18 Hz, Maximum

power 1.8 W

| 27 V/m 385 MHz Pulse modulation 18 Hz, Maximum

power 1.8 W

| 80 MHz to 800 MHz d =1.17√P

800 MHz to 2.7 GHz d =2.33√P

| 28 V/m 450 MHz, FM ± 5 kHz

deviation, 1 kHz sine, Maximum power 2 W

9 V/m 710, 745, 780, 5240,

5500, 5785 MHz, Pulse

modulation 217 Hz, Maximum power 0.2 W

28 V/m 810, 870, 930 MHz, Pulse

modulation 18 Hz, Maximum power 2 W

| 28 V/m 450 MHz, FM ± 5 kHz

deviation, 1 kHz sine, Maximum power 2 W

9 V/m 710, 745, 780, 5240,

5500, 5785 MHz, Pulse

modulation 217 Hz, Maximum power 0.2 W

28 V/m 810, 870, 930 MHz, Pulse

modulation 18 Hz, Maximum power 2 W

| 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).

WARNING – Portable RF equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part

of the System 9 Sterile Battery Charger (REF 9110-120- 000), including cables specified by the manufacturer. Otherwise, degradation of the performance of this

equipment could result.

| 28 V/m 1720, 1845, 1970, 2450

MHz, Pulse modulation 217 Hz, Maximum power 2 W

| 28 V/m 1720, 1845, 1970, 2450

MHz, Pulse modulation 217 Hz, Maximum power 2 W

| Field strengths from fixed RF transmitters, as determined

by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.

| |
Proximity magnetic fields

IEC 61000-4-39

| 65 A/m 134.2 kHz, pulse

modulation 2.1 kHz

| 65 A/m 134.2 kHz, pulse

modulation 2.1 kHz

| Interference may occur in the vicinity of equipment marked with the following symbol:
| 7.5 A/m 13.56 MHz, pulse modulation 50 kHz| 7.5 A/m 13.56 MHz, pulse modulation 50 kHz|

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 System 9 Sterile Battery Charger (REF 9110-120-000) is used exceeds the applicable RF compliance level above, the System 9 Sterile Battery Charger (REF 9110-120-000) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the System 9 Sterile Battery Charger (REF 9110-120-000).
• b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Certifications Underwriters Laboratories Inc. certification mark for United States and Canada. These products were tested and meet medical electrical equipment certification requirements, including compliance with applicable 60601 series standards. For additional information, contact Stryker.

Stryker Instruments
1941 Stryker Way
Portage, Michigan 49002 USA 269-323-7700 800-253-3210

Stryker European Operations Limited Anngrove, IDA Business & Technology Park Carrigtwohill, Co Cork
T45 HX08 Ireland

Stryker EMEA Supply Chain Services B. V. Frans Maasweg 2
Venlo 5928 SB, The Netherlands

UK Responsible Person Stryker UK Ltd. Stryker House Hambridge Road Newbury,
Berkshire
RG14 5AW
www.stryker.com

References

• International homepage | Stryker

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